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510(k) Exempt Medical Device Examples

The following are examples of 510(k) exempt medical devices. These devices are exempt from complying with premarket notification requirements subject to the limitations of exemptions; however, they are not exempt from certain general controls. For example, 510(k) exempt devices must:
  • be suitable for their intended use
  • be adequately packaged and properly labeled
  • have establishment registration and device listing forms on file with FDA
  • be manufactured under a quality system (with the exception of a small number of class I devices that are subject only to complaint files and general recordkeeping requirements)
The following list are examples of 510(k) exempt medical devices. This is not a comprehensive list. If you have questions about your specific devices, please contact us.

2,4-Dinitrofluorobenzene 2,4-Dinitrophenylhydrazine Abdominal Binder
Abdominal Orthosis Abrasive Disk Abrasive Point
Absorbent Tipped Applicator Acid Containing Fixative Acoustic Chamber
AC-Powered Automatic Perimeter AC-Powered Goniometer AC-Powered Keratoscope
AC-Powered Maxwell Spot AC-Powered Ophthalmic Chair AC-Powered Perimeter
AC-Powered Pupillometer AC-Powered Stereoscope AC-Powered Surgical Chair
Acridine Orange Adaptometer (Biophotometer) Adenoid Curette
Adenoid Punch Adenotome Adenovirus Serological Reagents
Adhesive Tape & Bandage Adhesive Tape Solvent Adjustable Hospital Bed
Adsorbent Liquid Chromatography Air and-or Water Syringe Unit Air Conduction Hearing Aid
Air Fluidized Bed Airway (Extension) Connector Albumin Immunological Test System
Albumin-Based Adhesive Alcian Blue Alcohol Containing Fixative
Aldehyde Fuchsin Aldolase Hydrazone Colorimetry Aldolase Test System
Alizarin Red Alkaline Phosphatase All Paraffin Formulations
All Types Retractor Alt-Sgpt Diazo Alt-Sgpt Hydrazone Colorimetry
Amalgam Dental Capsule Amino Acid Assay Culture Media Amniotome
Amputation Knife Amsler Grid Anaerobic Glove Box
Anaerobic Identification Kit Analyte Specific Reagents Analytical Balance
Androstenedione Radioimmunoassay Androsterone Radioimmunoassay Anesthesia Cabinet, Table & Tray
Anesthesia Stool Anesthetic Gas Mask Anesthetic Tube Warmer
Aniline Aniline Blue Animal & Human Sera
Anomaloscope Antibiotic Assay Culture Media Antibody Detection Candida Species
Antimicrobial Drug Removal Device Anti-Stammering Device Anti-Streptokinase
Antrum Perforator Antrum Punch Apathy'S Gum Syrup
Apgar Timer Apolipoproteins Arch Tracing Ink
Ardran-Crooks Measurement Cassette Arizona Spp. Serological Reagents Arm Board (With Cover)
Arm Sling Arm Support Arthroscopic Accessories
Articulation Paper Articulation Paper Forceps Articulators
Artificial Eye Artificial Larynx Artificial Nose
Assisted Reproductive Microscope ATP & Creatine Kinase (Enzymatic) Attic Punch
Audiometer Audiometer Calibration Set Auramine O
Automated Colony Counter Automated Slide Spinner Automated Slide Stainer
Automated Tissue Processor Automated Tissue Stainer Automated Urinalysis System
Awl Azan Counterstain Azocarmine B
Azocarmine G Azure A Azure C
B. Parapertussis Antigen B. Pertussis Antigen Backing & Facing Artificial Teeth
Bacterial Sialidase Vaginal Test Bagolini Lens Balloon Type Catheter
Base Metal Alloy Basic Fuchsin Battery Powered Photokeratoscope
Battery-Powered Euthyscope Battery-Powered Ionic Toothbrush Battery-Powered Keratoscope
Battery-Powered Retinoscope Battery-Powered Stereoscope Battery-Powered Transilluminator
Bed Board Bed Patient Monitor Bedpan
Bender Bending or Contouring Instrument Best'S Carmine
Biebrich Scarlet Binocular Loupe Binocular Vision Training Fixation
Biofeedback Device Biopsy Brush Biopsy Forceps Cover
Biopsy Percutaneous Device Bismarck Brown Y Bladder Evacuator
Bladder Neck Spreader Blastomyces Dermatitidis Eia Bleeding Time Device
Blender-Mixer Blood Cell Diluent Blood Donor Chair
Blood Grouping View Boxes Blood Lancet Blood Storage Freezer Refrigerator
Blood Tube Mixer Blood Volume Chromium-51 Blood-Bank Centrifuge
Blow Bottle Bone Cap Bone Hook
Bone Mill Bone Particle Collector Bone Screw Starter
Bone Skid Bone Tap Bouin'S Fluid
Brace Setting Twister Breast Binder Breath Measurement System
Breathing Circuit Breathing Mouthpiece Breathing System Collection Bottle
Breathing Tube Support Brilliant Cresyl Blue Brilliant Green
Brilliant Yellow Broach Bronchial Cannulae
Brucella Spp. Serological Reagents Burn Sheet C. Difficile Antigen
Cable Calculator-Data Processing Module Calculus Removal Hand Instrument
Caliper Caloric-Air Stimulator Caloric-Water Stimulator
Cane Cane, Tips & Pads Cannula Clamp
Capillary Blood Collection Tube Carbol Fuchsin Carbol Night Blue
Carbon-Dioxide Absorbent Carbon-Dioxide Absorber Cardiopulmonary Board
Cardiopulmonary Bypass Accessories Cardiopulmonary Emergency Cart Cardiovascular Biopsy Needle
Carmine Carnoy'S Solution Cast Bandage
Cast Component Cast Cover Cast Removal Instrument
Cast Shoe Catheter Accessories Catheter Adaptor
Catheter Connector Catheter Dilator Catheter Needle
Cell Culture Spinner System Cell Culture Suspension System Cell-Freezing & Reagents Apparatus
Celloidin Cement Dispenser Cement Mixer for Clinical Use
Cement Monomer Vapor Evacuator Cement Ventilation Tube Centrifugal Chemistry Analyzer
Cerclage Applier Cervical Mucus Viscometer Cervical Orthosis
Chelating Agent Chemical Solution Stains Chemiluminescent Light Source
Chilling Unit Chisel (Osteotome) Chlorazol Black E
Cholangiography Catheter Cholesterol (Total) Test System Chromatography (Liquid, Gel)
Chromatography (Thin Layer) Chromatography(Gas) Chrome Alum Hematoxylin
Chromosome Culture Kit Chymotrypsin Test System Circumcision Bell
Circumcision Shield Clamp Clarke'S Solution
Clavicle Splint Cleaning Brush Accessories Clearing Agent
Clearing Oil Clinical Color Change Thermometer Clinical Mercury Thermometer
Clinical Sample Concentrator Clinical Use Mass Spectrometer Clip Rack
Clip Removal Instrument Clip, Lens, Trial, Ophthalmic Closed Urine Drainage System
Cohesive Gel Nursing Pad Colchicine Collagen Corneal Shield
Collar & Crown Scissors Collecting Vessel Gas Collodion
Color Scanner Color Vision Plate Illuminator Color Vision Tester
Colostomy Appliance Colostomy Pouch Colostomy Spur Crusher
Compensated Thorpe Tube Flowmeter Complement Reagent Compression Dressing
Compression Instrument Conductive Shoe & Shoe Cover Congo Red
Contact Type Slide Stainer Continuous Irrigation Catheter Copper Sulfate Solution
Copper Test System Corkscrew Corneal Burr
Corneal Topographer Corneo-Scleral Punch Corrective Shoe Orthosis
Corrugated Rubber Sheath Corticoids Radioimmunoassay Corticosterone Radioimmunoassay
Counter (Beta, Gamma) Countersink Cranial Helmet for Protective Use
Creatine Conversion To Creatinine Cresyl Violet Acetate Crimp Plier
Crimp Ring Crown Remover Crutch
Crutch, Tips & Pads Cryostat Microtome Cryptosporidium Spp.
Crystal Violet for Histology Cuff Spreader Culdoscope & Accessories
Culture Media Supplement Cultured Animal & Human Cells Curette
Cysticercosis Reagents Cystine Chromatographic Cystotome
Cytocentrifuge Cytochemical Acid Phosphatase Cytological Preservative
Darrow Red Denis Brown Splint Densitometer-Scanner
Dental Accessories Tissue Culture Dental Amalgamator Dental Bur
Dental Depth Gauge Instrument Dental Diamond Instrument Dental Dressing Forceps
Dental Excavator Dental Floss Dental Hand Instrument
Dental Hand Instruments Dental Implant Accessories Dental Instrument Handle
Dental Needle Dental Operating Light Dental Protector
Dental Rapid Wax Applicator Dental Retractor Accessories Dental Sonography
Dental Stain Eraser Dental Surgical Curette Dental Surgical Elevator
Dental Surgical Tissue Scissors Dental Wax Carver Denture Adhesive
Denture Cleanser Denture Pad or Cushion Depth Gauge
Dermabrasion Brush Dermatome Dermatophyte Identification Kit
Detergent Device for Sealing Microsections Diagnostic Condensing Lens
Diagnostic Hruby Fundus Lens Diagnostic Microbiology Device Diagnostic X-Ray Tube Mount
Diagnostic-Surgical Loupe Dialysis Arm Clamp Dialysis Start-Stop Tray
Dialysis Tie Dialysis Tie Gun Dialyzer
Diastase Differential Hand-Tally Diluting Pipette
Disconnect Forceps Disk Guard Disposable Fluoride Tray
Disposable Hot or Cold Pack Disposable Medical Bedding Disposable Medical Scissors
Disposable Surgical Instrument Disposable Surgical Instrument Kit Disposable Suturing Needle
Disposable Vein Stripper Distometer Drape Adhesive
Dressing Adaptor Drill Brace Drill Handpiece (Brace)
Drying Unit Dye & Chemical Solution Stains Dye Powder Stains
Dye Solution Stains Ear Cannula Ear Curette
Ear Excavator Ear Knife Ear Rasp
Ear Scissors Ear Snare Ear Speculum Holder
Ear Spoon Ear Suction Tube Ear Wick
Ear-Lobe Perforator Earphone Cushion Eating Utensil
Echovirus Serological Reagents Ehrlich'S Hematoxylin Elastic Bandage
Elastic Binder Elastic Stocking Electric Cystometric Table
Electric Therapeutic Massager Electrical Recording Cystometer Electrical Urinometer
Electrically Powered Saw Electrode Cable Electrode Gel For Pulp Tester
Electrolytic Decalcifier Device Electrolytic Decalcifier Solution Electrophoresis Apparatus
Electrophoresis Instrumentation Elevator Embedding Container
Emesis Basin Endodontic Broach Endodontic Curette
Endodontic Paper Point Endodontic Pulp Canal File Endodontic Pulp Canal Reamer
Endodontic Root Canal Plugger Endodontic Silver Point Endoscope & Accessories
Endoscopic Bite Block Endoscopic Smoke Removal Tube Enema Kit (for Cleaning Purpose)
Enriched Culture Media ENT Applicator ENT Bur
ENT Cutting Block ENT Dropper ENT Drug Applicator
ENT Elevator ENT Esophageal Bougie ENT Esophageal Dilator
ENT Examining-Treatment Unit ENT Forceps ENT Knife
ENT Manual Surgical Instrument ENT Microrule ENT Mirror
ENT Mobilizer ENT Nasal Gouge ENT Piston Cutting Jig
ENT Powder Blower ENT Probe ENT Punch
ENT Retractor ENT Speculum ENT Speculum Holder
ENT Surgical Saw ENT Surgical Tray ENT Syringe
ENT Trocar ENT Wire Closure Forceps ENT Wire Crimper
ENT Wire Cutting Scissors Enucleating Snare Environmental Chamber
Enzyme Analyzer Eosin B Eosin Y
Episiotomy Scissors Epistaxis Balloon Erisophake
Erythrosin B Esophageal Stethoscope Esterase
Esthesiometer Estradiol Radioimmunoassay Estriol Radioimmunoassay
Estrone Radioimmunoassay Ether Dropper Ether Hook
Ethmoid Curette Ethmoid Punch Ethyl Eosin
Etiocholanolone Radioimmunoassay Eustachian Bougie Eustachian Catheter
Eustachian Filliform Set Evaporator Examination & Treatment Chair
Examination Gown Examination Light Exercise Components
Exercise Parallel Bars Exophthalmometer Expressor
External Adhesive Prosthesis External Brace Ankle Joint External Brace Component Stirrup
External Brace Hip Joint External Brace Knee Joint External Breast Prosthesis
External Limb Component Hip Joint External Limb Component Knee Joint External Limb Prosthetic Component
External Pelvimeter External Penile Rigidity Device Extractor
Eye Knife Test Drum Eye Pad Face Plate Hearing Aid
Facebow Facial Fracture Appliance Fast Green
Fast Red Salt B Fastidious Organisms Kit Fatty Acids Titrimetric
Felt (Campimeter) Tangent Screen Femoral Neck Punch Fetal Stethoscope
Fiber Optic Dental Light Fiberoptic Retractor File
Filiform & Filiform Follower Film Dosimetry System Accessory Finger Exerciser
Fixed Size Cervical Dilator Flame Emission Photometer Flask Spinner
Flexible Diagnostic Fresnel Lens Flexible Stone Dislodger Flotation Cushion
Flotation Therapy Bed Fluid Evacuator System Fluorescence Wood'S Light
Fluorescence-U.V. Microscope Fluorometer Fontanna Silver Solution
Foot Examination Tool Force-Measuring Platform Forceps
Fork Formaldehyde (Formalin, Formol) Formalin Ammonium Bromide Solution
Formalin-Containing Fixative Formalin-Saline Formalin-Sodium Acetate Solution
Formol Calcium Solution Fornixscope Freezer
Freezing Attachment Microtome Frontal-Sinus Rasp Fuchsin Acid
Fusion & Stereoscopic Target Gardnerella Vaginalis DNA Probe Gas Pressure Calibrator
Gas Calibration Flowmeter Gas Cylinder Pressure Regulator Gas Flow Transducer
Gas Generating Device Gas Mask Head Strap Gas Pressure Transducer
Gas Volume Calibrator Gastric Acidity Tubeless Analysis Gastrin Radioimmunoassay
Gastroenterologic Needle Holder Gastro-Urology Evacuator Gastro-Urology Hook
Gastro-Urology Needle Gastro-Urology Probe & Director Gastro-Urology Stylet
Gastro-Urology Tourniquet Gastro-Urology Trocar Gelatin
Gelatin For Specimen Adhesion Gelatin-Formalin General & Plastic Surgery Cannula
General & Plastic Surgery Clamp General & Plastic Surgery Elevator General & Plastic Surgery File
General & Plastic Surgery Forceps General & Plastic Surgery Gouge General & Plastic Surgery Hook
General & Plastic Surgery Mallet General & Plastic Surgery Mirror General & Plastic Surgery Rasp
General & Plastic Surgery Spatula General & Plastic Surgery Stylet General Laboratory Timer
General Purpose Reagent Geriatric Chair Giardia Spp.
Giemsa Stain Gingival Fluid Measurer GLC Column Supports
GLC Columns GLC Gases GLC Liquid Coating
GLC U.V. Monitor Glenner'S Stain Globulin Electrophoretic
Globulin Method Turbidimetric Globulin Nephelometric Method Globulin Tryptophan Measurement
Glucagon Radioimmunoassay Glutaraldehyde Glutathione Chromatographic
Gold & Stainless Steel Cusp Gold Chloride Gold-Based Noble Metal Alloy
Gonadal Shield Goniometer with Electrodes Gonioscopic Prism
Gram Negative Identification Panel Gram Positive Identification Panel Grams Iodine
Grooming Adaptor Gugol Blue Solution Gutta-Percha
Gynecological Biopsy Forceps Gynecological Cerclage Needle Gynecological Fibroid Hook
Haemophilus Spp. DNA-Probe Haidinger Brush Hammer Surgical Head
Hand-Carried Stretcher Haploscope Heart Stabilizer
Heart-Valve Test Probe Heat & Moisture Condenser Heat Source for Bleaching Teeth
Heating Block Heat-Sealing Device Heimlich Maneuver Assist Device
Heinz Body Stains Helly Solution Hematein Acid
Hematocrit Centrifuge Hematocrit Measuring Device Hematology Quantitative Pipette
Hematology Stains Hematoxylin Hematoxylin Harris'S
Hematoxylin Mayer'S Hematoxylin Weigert'S Hemocytometer
Hemostat Hemostatic Clip Applier Heparin
Hernia Support Histidine Chromatographic Histidine Microbiological
Hollow Mill Set Homemaking Utensil Hospital Bassinet
Hot Water Pasteurization Device Hot-Cold Water Bottle Humidifier for Home-Use
Hyaluronidase Hydraulic Cystometric Device Hydrogel Nursing Pad
Hydrogel Wound Dressing Hydrophilic Beads Hydrophilic Wound Dressing
Hydroxyproline Test System Hygiene Adaptor Hysteroscope Accessories
Ice Bag IGG Immunoassay Reagent Ileostomy Urinary Bag
Illuminated Speculum Immersion Type Slide Stainer Impactor
Incubators-Water Bath Indigocarmine Indirect Fluorescent Antibody Test
Infant Oxygen Hood Infiltrator Inflatable Extremity Splint
Inflation Bulb for an Endoscope Infusion Catheter Infusion Stand
Inhibin-A Enzyme Immunoassay Injection Cannula Inserter-Remover Contact Lens
Instrument Surgical Guide Instrument Surgical Tray Instrument, Clip Forming-Cutting
Insulin Vial Protector-Holder Interconnected Metal Sound Intestine Bag
Intranasal Septal Splint Intraocular Lens Guide Intraoral Dental Drill
Intraoral Dental Wax Iodine (Tincture) Ion Papers
Ion-Exchange Adsorbents Ion-Exchange Chromatography Ion-Exchange Resins
Iris Retractor Clip Iron Chloride-Weigert Iron Stains
Irrigating (Non Dental) Syringe Irrigation Catheter Isotonic Solution
Janus Green B Jaw Tracking Device Jenner Stain
Jet Lavage Joint Ring Karaya Denture Adhesive
Ketones Nitroprusside Knee Cage Knee-Shank-Ankle-Foot Assembly
Lachrymal Dilator Lachrymal Probe Lachrymal Sac Rongeur
Lactic Acid Test System Lambs Feeding Nipple Laparotomy Ring
Laryngeal Injection Set Laryngeal Knife Laryngeal Saw
Laryngeal Trocar Laryngectomy Tube Laryngostroboscope
Laser Generating Gas Lead Syringe Holder Leaded Apron
Lead-Lined Radiographic Cone Lectins & Protectins Legionella DNA-Reagents
Lens Measuring Instrument Leuco-Patent Blue Leukocyte Peroxidase Test
Leukocyte Typing Test Leukotome Lice Combs
Ligature Carrier Light Green Limb Brace Orthosis
Limb Cover Limb Orthosis Limb Truncal-Orthosis Orthosis
Line Clamp Line Isolation Monitor Lipase Test System
Lipoprotein Test System Lipoprotein (A) Test System Lipoproteins Colorimetric Method
Lipoproteins Method Turbidimetric Lipoproteins Nephelometric Method Liquid Chromatography Columns
Liquid Medication Dispenser Listeria Spp. Serological Reagents Low-Vision Hand-Held Magnifier
Low-Vision Hand-Held Telescope Low-Vision Microscope Spectacle Low-Vision Spectacle Telescope
Lugol'S Solution Lumbar Orthosis Lumbo-Sacral Orthosis
Luteinizing Hormone (LH) Test Luxol Fast Blue Lymphocyte Separation Medium
Maddox Lens Magnetic Locator Magnifying Spectacle
Malachite Green Mallet Malleus Nipper
Mallory'S Trichrome Stain Manual Algesimeter Manual Bed
Manual Cell Diluting Fluid Manual Colony Counter Manual G-U Surgical Instruments
Manual Nebulizer Pump Manual Ophthalmic Chair Manual Osteotome
Manual Perimeter Manual Platelet Counting Manual Pupillometer
Manual Refractor Manual Saw & Accessories Manual Stethoscope
Manual Surgical Chisel Manual Surgical Instrument Manual Therapeutic Massager
Manual Toothbrush Margin Finishing Knife Martius Yellow
Massaging Pick Mastoid Chisel Mastoid Gauge
Mastoid Rongeur Mastoid Searcher Matrix Retainer
Measuring Device for Panendoscope Measuring Ear Rod Measuring Gauge
Mechanical Adjustable Chair Mechanical Denture Cleaner Mechanical Table
Mechanical Treadmill Mechanical Urinometer Mechanical Walker
Media Dispensing-Stacking Device Medical Absorbent Fiber Medical Chair & Table
Medical Devices Disinfectant Medical Devices Disinfector Medical Drill Bit
Medical Examination Device Medical Examination Table Medical Gas Yoke Assembly
Medical Insoles Medical Scoop Medical Screwdriver
Medical Support Stocking Medication Reminder Membrane Filter Unit
Mercury and-or Alloy Dispenser Metal Vaginal Speculum Metallic Containing Fixative
Metanil Yellow Methenamine Silver Methyl Green
Methyl Orange Methyl Violet 2B Methylene Blue Thiocyanate
Methylene Blue, Tissue Stain Methylene Violet Micro Chemistry Analyzer
Micro Mixer Micro Pipette Microbial Growth Monitor
Microbiologic Stains Microscope Condensers Microscope Lamps
Microscope Light Microscope Micrometers Microscope Slide Coverslips
Microscope Slides Microscope Stages Microsedimentation Centrifuge
Microsurgical Ear Hook Microsurgical Ear Pick Microsurgical Instrument
Microtitrator Microtome & Accessories Middle-Ear Chisel
Miniature Pressure Transducer Moist Heat Pack Mounting Media
Mouth Gag Mouth Mirror Mucicarmine
Mucopolysaccharides Colorimetric Muller'S Colloidal Iron Multi-Analyte Controls Unassayed
Multiple Lumen Catheter Mumps Virus Serological Reagents Mycobacteria Identification
Mycoplasma Detection Kit Mycoplasma Detection Media Mycoplasma Spp. DNA-Reagents
Myringotomy Knife Myringotomy Tube Inserter Nasal Chisel
Nasal Curette Nasal Dilator Nasal Inhaler
Nasal Knife Nasal Punch Nasal Rasp
Nasal Rongeur Nasal Saw Nasal Scissors
Nasal Snare Nasal Splint Nasopharyngeal Airway
Nasopharyngeal Catheter Nearpoint (Punctometer) Ruler Needle-Type Epilator
Neisseria Controls Neonatal Eye Pad Nephelometer
Nephrostomy Catheter Neuramininase (Sialidase) Neurosurgical Chair
Neurosurgical Headrest Neurosurgical Suture Needle Neutral Buffered Formalin
Neutral Red Newcomer'S Solution Nigrosin
Nile Blue Nipple Shield Noble Metal Alloy
Non-Electric Biopsy Forceps Non-Electrical Clamp Non-Electrical Cysto Table
Non-Electrical Snare Non-Electrical Surgical Chair Non-Fluid Filled Teething Ring
Non-Illuminated Speculum Noninflatable Extremity Splint Noninvasive Traction Component
Non-Invasive Traction Component Noninvasive Tubing Non-Measuring Exerciser
Nonpneumatic Tourniquet Non-Powered Breast Pump Non-Powered Communication System
Nonpowered Dynamometer Nonpowered Goniometer Non-Powered Rectal Probe
Non-Powered Surgical Instrument Non-Rebreathing Oxygen Mask Nonresorbable Gauze-Sponge
Non-Rigid Laryngoscope Non-Self-Retaining Retractor Non-Sterile Gelfoam Punch
Non-Sterile Gustometer Non-Surgical Isolation Gown Non-Surgical Tongue Depressor
Nose Clip Nuclear Anthropomorphic Phantom Nuclear Fast Red
Nuclear Flood Source Phantom Nuclear Rectilinear Scanner Nuclear Sealed Calibration Source
Nuclear Uptake Probe Nuclear Whole Body Counter Nuclear Whole Body Scanner
Nystagmus Tape Obstetric pH Paper Occlusive Wound Dressing
Ocular Esthesiometer Ocular Marker Ocular Surgery Irrigation Device
Oil Red O Oil Soluble Mounting Media Olfactory Test Kit
One-Piece Scalpel Operating-Room Scrub Brush Operating-Room Shoe Cover
Operating-Room Shoes Operating-Room Stool Operating-Room Suction Apparatus
Operating-Room Table Operating-Room Table & Attachments Operating-Room Table Accessories
Operative Amalgam & Foil Condenser Operative Amalgam Carrier Operative Burnisher
Operative Curette Operative Cutting Instrument Operative Dental Amalgam Carver
Operative Explorer Operative Margin Finishing File Operative Pliers
Ophthalmic (Flieringa) Ring Ophthalmic Aberrometer Ophthalmic Bar Prism
Ophthalmic Bar Reader Ophthalmic Caliper Ophthalmic Cannula
Ophthalmic Conformer Ophthalmic Curette Ophthalmic Electrolysis Unit
Ophthalmic Eye Shield Ophthalmic Eyelid Clamp Ophthalmic Fixation Device
Ophthalmic Forceps Ophthalmic Fresnel Prism Ophthalmic Headband Mirror
Ophthalmic Hook Ophthalmic Images Storage Device Ophthalmic Instrument Cabinet
Ophthalmic Instrument Stand Ophthalmic Instrument Table Ophthalmic Knife
Ophthalmic Lens Gauge Ophthalmic Manual Trephine Ophthalmic Muscle Clamp
Ophthalmic Prism Reader Ophthalmic Projector Ophthalmic Refractometer
Ophthalmic Retractor Ophthalmic Rotary Prism Ophthalmic Scissors
Ophthalmic Spatula Ophthalmic Specula Ophthalmic Spoon
Ophthalmic Spud Ophthalmic Suturing Needle Ophthalmic Tantalum Clip
Ophthalmic Trial Frame Ophthalmic Trocar Cannula Opticokinetic Drum
Oral Cavity Evacuator Oral Hygiene Rubber Tip Oral Irrigation Unit
Oral Screw Orange G Orange II
Orbital Compressor Orbital Depressor Orcein
Orchidometer Oropharyngeal Airway Orthodontic Band Driver
Orthodontic Band Pusher Orthodontic Band Setter Orthodontic Bracket Aligner
Orthodontic Elastic Band Orthodontic Material Band Orthodontic Metal Bracket
Orthodontic Plier Orthodontic Preformed Band Orthodontic Spring
Orthodontic Tube Orthodontic Wire Orthodontic Wire Clamp
Orthopedic Burr Orthopedic Cutting Instrument Orthopedic Knife
Orthopedic Needle Holder Orthopedic Spatula Orthopedic Tape
Orthopedic Wire Passer Orthotic-Prosthetic Monitor Orth'S Solution
Osmic Acid Osmium Tetroxide Osmometer
Osmotic Fragility Testing Ossicle Holding Clamp Ossicular Finger Vise
Osteotome Ostomy Collector Ostomy Pouch & Accessories
Ostomy Protector Ostomy Size Selector Ostomy Stomal Appliance Cement
Otoscope Ouchterlony Agar Plates Overhead Supported Arm Sling
Oxalate Test System Oxygen Mask Oxygen Nasal Cannula
Oxygen Nasal Catheter Oxygen Tent Pacemaker Charger
Pacemaker Polymeric Mesh Bag Pacemaker Service Tools Pacemaker Test Magnet
Pantograph Papain Papanicolau Stain
Paper Chart Recorder Paraffin Dispensers Paraffin Melting Point Apparatus
Paraffin Melting Pot Paraffin Ovens Paraformaldehyde
Passer Paste-On Device for Incontinence Pasteur Pipette
Patient Lift Patient Personal Hygiene Kit Patient Position Support
Patient Restraint Stretcher Patient Rotation Bed Patient Scale
Patient Stand-On Scale Patient Transfer Device Pediatric Catheter
Pediatric Open Hospital Bed Pelvic Belt Pelvic Support Band or Belt
Penile Clamp Percussor Perfusion Apparatus
Perineal Binder Periodic Acid Periodontic Curette
Periodontic File Periodontic Hoe Periodontic Knife
Periodontic Marker Periodontic Probe Periodontic Scaler
Peritoneal Catheter Permanent Magnet Personnel Protective Shield
pH Buffer pH Dye-Indicator pH Meter
Pharmacy Compounding System-Device Phase Contrast Microscope Phenylketones Chromogenesis
Phloxine B Phonocardiograph Phospholipids Chromatographic
Phosphotungstic Acid Hematoxylin Photokeratoscope Phytohemaglutinin M
Picro Methyl Blue Pill Crusher-Cutter Pin Crimper
Pinwheel Pipetting & Diluting Station Plasma Oncometer
Plasma Viscometer Plasma Viscometry Rotating Disc Plastic Surgery & Accessories Kit
Plinth Pneumatic Tourniquet Pneumatically Powered Saw
Pocket Battery Boxes Polarimeter Poliovirus Serological Reagents
Polishing Agent Strip Polishing Agent Wheel Polyethylene Glycol (Carbowax)
Polyethylene Glycol Preservative Ponceau Stain Porphobilinogen Test System
Portable Leakage Current Alarm Post Surgical Pylon Posture Chair
Potassium Periodate Potentiating Media Powered Communication System
Powered Exerciser Powered Heating Pad Powered Heating Unit
Powered Nasal Irrigator Powered Parallel Bars Powered Patient Transfer Device
Powered Saw & Accessories Powered Table Powered Toothbrush
Powered Treadmill Precision Attachment Preformed Anchor
Preformed Bar Preformed Clasp Preformed Crown
Preformed Cusp Preformed Gold Denture Teeth Preformed Impression Tray
Preformed Tooth Positioner Pregnanetriol Gas Chromatography Pregnenolone Radioimmunoassay
Prescription Spectacle Lens Pressure Applying Device Pressure Infusor for I.V. Bags
Pressure Tubing & Accessories Probe Progesterone Radioimmunoassay
Prone Scooter Board Prophylaxis Cup Prosthesis Alignment Device
Prosthesis Driver Prosthesis Heart-Valve Holder Prosthesis Heart-Valve Sizer
Prosthesis Modification Instrument Prosthesis Valve Protargol S
Protective Apron Protein-Bound Iodine Protractor
Pseudomonas Identification Kit Ptosis Crutch Punch Catheter Instrument
Pupillograph Pyronin Pyruvate Kinase Test System
Pyruvic Acid Test System Quality Control Slides Radiographic Film
Radiographic Film Marking System Radiographic Grid Radiographic Head Holder
Radiographic Intensifying Screen Radiographic Protective Curtain Radiographic Protective Glove
Radiographic Table Radiographic Test-Pattern Radiographic-Film Illuminator
Radiologic Patient Cradle Radiologic Table Radiological Eye Shield
Radionuclide Teletherapy Source Radionuclide Test-Pattern Phantom Rasp
Reamer Rebreathing Device Rechargeable Battery Boxes
Rechargeable Replacement Battery Recreational Adaptor Rectal Catheter
Rectal Dilator Rectal Speculum Red-Cell Diluting Fluid
Red-Cell Lysing Products Products Red-Violet LB Refractometer
Removable (Skin) Clip Removable (Skin) Staple Renal Water Jet Catheter System
Reovirus Serological Reagents Resazurin Tablet Reservoir Bag
Resin Applicator Resin Impression Tray Material Resorcin Fuchsin
Reticulocyte Stain Retractor Reusable Image Media
Reusable Suturing Needle Reusable Vein Stripper Reuseable Hot or Cold Pack
Rhinovirus Serological Reagents Ribdam Richardson Glycol Fixative
Rickettsia Serological Reagent Rickettsia Serological Reagents Rigid Cervical-Thoracic Orthosis
Rigid Laryngoscope Ring Cutter Roll Cotton
Roller Apparatus Romanowsky Stains Rongeur
Root Canal Endodontic Preparer Root Canal Post Rose Bengal
Rotary Microtome Rubber Dam Rubber Dam Clamp
Rubber Dam Clamp Forceps Rubber Dam Frame Rulers & Calipers Measuring Tape
Sacculotomy Tack Inserter Safety Walk Cane Safranin
Sahli Pipette Saliva Absorber Saliva Ejector Mouthpiece
Salmonella Spp. DNA-Reagents Salpingeal Curette Saw
Scalpel Blade Scalpel Handle Scanning Bed
Scavenging Mask Scented-Deodorized Menstrual Pads Schiff Reagent
Schirmer Strip Sclera Marker Scleral Shell
Sedimentation Rate Tube Selective Broth Culture Media Self-Retaining Retractor
Serratia Spp. Serological Reagents Shaker-Stirrer Shellac Base Plate
Shigella Spp. DNA-Reagents Shigella Spp. Serological Reagents Signal Isolation System
Silicate Protector Silicone Elastomer Silver Carbonate Solution
Silver Nitrate Sinus Cannula Sinus Irrigator
Sinus Trephine Sinus Trocar Sirius Red
Sitz Bat Skiascopic Rack Skin Closure System
Skin Marker Skin Pressure Protector Skin Protectant Liquid Bandage
Skull Plate Anvil Skull Punch Skullplate Screwdriver
Slide Culture Chamber Slide Warming Lamps Slide Warming Table
Sliding Microtome Smear Synthetic Sprays Snake-Bite Suction Kit
Socket Positioner Socket Pusher Sodium Periodate
Soft Rib Fracture Orthosis Soft Sacroiliac Orthosis Solid Medication Dispenser
Sorbitol Dehydrogenase Test System Specimen Container Spectacle Dissociation Test
Spectacle Frame Spectacle Lens Specula Accessories
Sphere Introducer Sputum Blender Staphylococcus Aureus DNA-Probe
Staple Driver Stereo Campimeter Stereopsis Measuring Instrument
Sterile Gelfoam Punch Sterile Gustometer Sterile Label or Tag
Sterile Specimen Trap Stethoscope Head Stirrups
Stomach pH Electrode Stomal Bag Strep Pneumoniae DNA-Probe
Streptolysin O Subungual Hematoma Drill Suction Catheter & Tip
Suction Operatory Unit Sudan Black B Sudan III
Sudan IV Sun Tan Booth Sunglasses
Support Gels Suprapubic Cannula & Trocar Surgeon'S Gloving Cream
Surgical Apparel Accessories Surgical Biopsy Punch Surgical Bit
Surgical Bone Chisel Surgical Bone File Surgical Bur
Surgical Camera & Accessories Surgical Camera Film Surgical Camera Frame
Surgical Camera Holder Surgical Camera Lens Surgical Camera Tape
Surgical Cannula Surgical Cap Surgical Clamp
Surgical Clip Applier Surgical Contractor Surgical Curette
Surgical Cutter Surgical Dissector Surgical Dress
Surgical File Surgical General Scissors Surgical Gouge
Surgical Hammer Surgical Headlight Surgical Helmet
Surgical Hemostat Surgical Hook Surgical Instrument Motor
Surgical Knife Surgical Mallet Surgical Marking Pen
Surgical Metal Tongue Depressor Surgical Microscope Surgical Microscope & Accessories
Surgical Needle Guide Surgical Orthopedic Scissors Surgical Osteotome Chisel
Surgical Pin Driver Surgical Pliers Surgical Punch
Surgical Rasp Surgical Razor Surgical Retainer
Surgical Rongeur Forceps Surgical Saw Blade Surgical Skin Degreaser
Surgical Skin Graft Expander Surgical Snare Surgical Spatula
Surgical Sponge Counter Surgical Sponge Scale Surgical Staple Applier
Surgical Stapler Surgical Stripper Surgical Stylet
Surgical Suit Surgical Table Cushion Surgical Tooth Extractor Forceps
Surgical Tray Suture Retention Device Switching (Ploss) Valve
Syringe Holder Adaptor Tamp Target Tangent Screen
Tee (Water Trap) Drain Temperature Regulator Template
Temporary Training Splint Therapeutic Bed Therapeutic Medical Binder
Therapeutic Scrotal Support Therapeutic Vibrator Thermostated Curvette
Thionin Thoracic Orthosis Thromboplastin Generation Test
Tissue Cassettes Tissue Culture Dish Tissue Culture Flask
Tissue Culture Roller Bottle Tissue Culture Tube Tissue Flotation Bath
Tissue Grinder Tissue Sieves Titan Yellow
TLC Alumina Fluorescent Indicator TLC Alumina Plate TLC Atomizer
TLC Cellulose Plate TLC Developing Tanks TLC Light U.V.
TLC Silica Gel Plate Toluidine Blue Tongue Scraper
Tonometer Sterilizer Tonsil Dissector Tonsil Guillotine
Tonsil Knife Tonsil Punch Tonsil Screw
Tonsil Snare Tonsil Suction Tube Tonsil Suturing Hook
Tonsil Suturing Needle Tonsillectome Topical Approximation System
Total Protein Lowry (Colorimetric) Total Protein Refractometric Total Protein Turbidimetric
Toynbee Diagnostic Tube Trabeculotome Trabeculotomy Probe
Tracheal Bistoury Tracheal Dilator Tracheal Hook
Tracheal Trocar Tracheal Tube Cleaning Brush Tracheal Tube Fixation Device
Tracheal Tube Stylet Tracheobronchial Suction Catheters Tracheotome
Traction Accessories Traction Apparatus Traction Head Halter
Traction Splint Transfer Aid Transverse Rotator
Trephine Trial Lens Ophthalmic Set Trichinella Spiralis Elisa
Trichomonas Screening Kit Trichomonas Vaginalis DNA Probe Triglycerides Colorimetric Method
Triglycerides Fluorometric Method Triglycerides Method Turbidimetric Triiodothyronine Uptake Radioassay
Truncal Orthosis for Dysmenorrhea Trypan Blue Trypsin
Trypsin Test System Tube Impression & Matrix Tube Introduction Forceps
Tubing & Tubing-Filter Fits Tumor Localization Needle Tuning Fork
Tweezer-Type Epilator Two-Point Discriminator Ultra Microtome
Umbilical Occlusion Device Umbilical Scissors Umbilical Truss
Uncompensated Thorpe Tube Unpowered Dialysis Chair Unscented Menstrual Pad
Ureteral Catheter Adaptor Ureteral Catheter Connector Ureteral Catheter Holder
Ureteral Stone Dislodger Ureteral Stylet Ureterostomy Urine Collecting Bag
Urethral Sound Urethrometer Urinal
Urinary Carbohydrate Analysis Kit Urinary Drainage Collection Kit Urinary Phenylketones Test System
Urinary Protein Test System Urinary Urobilinogen Test System Urine Collection Bag
Urine Collector & Accessories Urine Flow Rate Measuring Device Urine Leukocyte Test
Urine Screening Kit Uroflowmeter Urological Bougie
Uroporphyrin Fluorometric Uroporphyrin Spectrophotometric Urosheath Type Incontinence Device
Uterine Clamp Uterine Curette Uterine Packer
Uterine Sound Vacuum Collection Bottle Vacuum Regulator
Vaginal Applicator Vaginal Insufflator Vaginal Retractor
Van Gieson'S Picro-Fuchsin Van Gieson'S Stain Vein Extractor
Vein Press Vein Stabilization Device Ventilator, Tubing & Support Set
Venturi Mask Vertebroplasty Injector Vial Shield
Vision Aid Vision Image Intensification Aid Visual Acuity Chart
Vitamin Assay Culture Media Walker, Tips & Pads Washer of Body Waste Receptacles
Water Purifier Water Circulating Hot or Cold Pack Water Soluble Mounting Media
Water Vapor Analyzer Weigert'S Iron Hematoxylin Wheelchair Accessories
Wheelchair Anti-Tip Device Wheelchair Armboard Wheelchair Armrest
Wheelchair Belt Wheelchair Commode Attachment Wheelchair Components
Wheelchair Curb Climber Wheelchair Cushion Wheelchair Extension Brake
Wheelchair Footrest Wheelchair Handrim Wheelchair Hill Holder
Wheelchair Lap Board Wheelchair Narrowing Attachment Wheelchair Platform Scale
Wheelchair Pusher Cuff Wheelchair, Crutch & Cane Holder Wheelchair, Head & Trunk Support
Wheeled Stretcher White-Cell Diluting Fluid Whole Human Plasma Test System
Wire Clasp Wire Cutter Wire Holding Forceps
Wire Loop Wire Twister Chair With Casters
Wrench Wright'S Stain X-Ray Beam Aligner
X-Ray Collimator X-Ray Film Holder Xylose Colorimetric
Xylose P-Bromoaniline Yeast DNA Probe Yeast Identification Kit
Yeast Screening Kit Zenker'S Solution Zinc Oxide Eugenol



 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
























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