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Medical Device 510(k) Examples

The following are examples of Medical Devices for which companies must obtain 510(k) clearance from the U.S. FDA before such devices may be sold in the United States.

NOTE: The following are examples only. This is not a comprehensive list. If you have questions about your specific devices, please contact us.

Absorbable Poly Surgical Suture Absorbable Surgical Gut Suture AC-Powered Slitlamp Biomicroscope
Activated Whole Blood Clotting Time Tests Airbrush Alpha-1-Lipoprotein Immunological Test System
Amalgam Alloy Anesthesia Conduction Catheter Anesthetic Vaporizer
Aneurysm Clip Angiographic X-Ray System Antimicrobial Susceptibility Test Disc
Antinuclear Antibody Immunological Test Antinuclear Antibody Immunological Test Antithrombin III Assay
Apnea Monitor Aqueous Shunt Arrhythmia Detector and Alarm
Arthroscope Assisted Reproduction Laser System Auditory Impedance Tester
Automated Cell Counter Automated Cell-Locating Device Automated External Defibrillator
Automated Hemoglobin System Automated Heparin Analyzer Automatic Radiographic Film Processor
Beta-Glucan Serological Assays Bicarbonate|Carbon Dioxide Test Blood Carbon Dioxide Partial Pressure Analyzer
Blood Hydrogen Ion Concentration Analyzer Blood Oxygen Partial Pressure Analyzer Blood Pressure Computer
Blood Specimen Collection Device Bone Cutting Instrument Bone Cutting Instrument and Accessories
Bracket Adhesive Resin and Tooth Conditioner Breath Nitric Oxide Test System Breathing Circuit Bacterial Filter
Breathing Frequency Monitor Bronchial Tube Bronchoscope (Flexible or Rigid) and Accessories
B-Type Natriuretic Peptide Test System Calcium Hydroxide Cavity Liner Calibrator
Calibrator for Cell Indices Calibrator for Hemoglobin|Hematocrit Calibrator for Platelet Counting
Calibrator for Red & White Cell Count Cannabinoid Test System Carbon Dioxide Gas Analyzer
Cardiac Monitor Cardiopulmonary Blood Filter Cardiopulmonary Bypass Adaptor
Cardiopulmonary Bypass Arterial Line Blood Filter Cardiopulmonary Bypass Defoamer Cardiopulmonary Bypass Oxygenator
Cardiovascular Blood Flowmeter Cardiovascular Intravascular Filter Cardiovascular Intravascular Filter
Cartridge Syringe Cartridge Syringe Catheter Tip Pressure Transducer
Catheter Tip Pressure Transducer Cavity Varnish Central Nervous System Fluid Shunt and Components
CFTR Gene Mutation Detection Chloride Test System Cholesterol (Total) Test System
Clinical Electronic Thermometer Clinical Multiplex Test Instrumentation Clinical Toxicology Calibrator
Clitoral Engorgement Device Coagulation Instrument Coating Material for Resin Fillings
Cocaine and Cocaine Metabolite Test Colposcope Computed Tomography X-Ray System
Computed Tomography X-Ray System Computerized Labor Monitoring System Condom
Condom With Spermicidal Lubricant Continuous Flush Catheter Contraceptive Diaphragm and Accessories
Cortical Electrode C-Reactive Protein Immunological Test Creatinine Test System
Cutaneous Carbon Dioxide Monitor Cutaneous Electrode Cutaneous Oxygen (Pco[Bdi2]) Monitor
Cytocentrifuge Dental Cement Dental Electrosurgical Unit
Dental Electrosurgical Unit and Accessories Dental Hand Instrument Dental Handpiece and Accessories
Dental Mercury Dental Operative Unit Dental Operative Unit and Accessories
Dental Sonography Device Denture Relining, Repairing, or Rebasing Resin Denture Relining, Repairing, or Rebasing Resin
Deodorized Menstrual Pad Deodorized Menstrual Tampon Diagnostic Electromyograph Needle Electrode
Diagnostic Spirometer Diagnostic Ultrasonic Transducer Drug Metabolizing Enzyme Genotyping
Dry-Heat Sterilizer Dura Substitute Ear Oximeter
Ear Prosthesis Echocardiograph Electrical Continence Device
Electrocardiograph Electrocardiograph Electrode Electrocardiograph Lead Switching Adaptor
Electrocardiograph Surface Electrode Tester Electrohydraulic Lithotriptor Electronic Monitor for Gravity Flow Infusion
Electrostatic X-Ray Imaging System Emission Computed Tomography Endodontic Stabilizing Splint
Endolymphatic Shunt Tube With Valve Endosseous Dental Implant Abutment Enterovirus Nucleic Acid Assay
Erythropoietin Assay Esophageal Prosthesis Esophagoscope (Flexible or Rigid) and Accessories
External Negative Pressure Ventilator External Pacemaker Pulse Generator Extracorporeal Shock Wave Lithotripter
Extraoral Orthodontic Headgear Extraoral Source X-Ray System Extravascular Blood Pressure Transducer
Factor Deficiency Test Fetal Ultrasonic Monitor and Accessories Fibrin Monomer Paracoagulation Test
Fibrinogen|Fibrin Degradation Products Assay Finger Joint Polymer Constrained Prosthesis Fluorescencein Situhybridization Enumeration
Gas Machine for Anesthesia or Analgesia Gas Machine for Anesthesia or Analgesia Gas-Powered Jet Injector
Gas-Scavenging Apparatus Gastrointestinal Tube and Accessories Gene Expression Profiling Test
Glucose Test System Glucose Test System Group Hearing Aid or Group Auditory Trainer
Gynecologic Surgical Laser Halothane Gas Analyzer Hearing Aid
Hearing Aid Calibrator Hearing Aid Calibrator and Analysis System Hemodialysis System and Accessories
Heparin Assay Hepatitis A Virus (HAV) Serological Assays Hepatitis A Virus Serological Assays
Herpes Simplex Virus Serological Assays High Permeability Hemodialysis System Hip Joint Prosthesis
Home Uterine Activity Monitor Hot or Cold Disposable Pack Human Chorionic Gonadotropin Test
Human Dura Mater Hydrophilic Resin Coating for Dentures Hyperbaric Chamber
Hyperbaric Chamber Hypodermic Single Lumen Needle Hysteroscope and Accessories
Hysteroscopic Insufflator Image-Intensified Fluoroscopic X-Ray Immersion Hydrobath
Implantable Pacemaker Pulse Generator Impression Material Infrared Lamp
Infusion Pump Intervertebral Body Fusion Device Intervertebral Body Fusion Device
Intra-Aneurysm Pressure Measurement Intracranial Pressure Monitoring Device Intramedullary Fixation Rod
Intraocular Lens Guide Intraoral Ligature and Wire Lock Intraosseous Fixation Screw or Wire
Intraosseous Fixation Screw Or Wire Intravascular Administration Set Intravascular Infusion Port and Catheter
Iontophoresis Device Jaw Tracking Device Keratome
Keratoprosthesis Knee Joint Femorotibial Prosthesis Knee Joint Femorotibial Prosthesis
Knee Joint Patellofemorotibial Prosthesis Laparoscopic Insufflator Limb Orthosis
Long-Term Intravascular Catheter Low-Density Lipoprotein Immunological Test System Magnetic Resonance Diagnostic Device
Mammographic X-Ray System Manual Emergency Ventilator Measuring Exercise Equipment
Mechanical Lithotriptor Mediastinoscope and Accessories Medical Charged-Particle Radiation Therapy System
Medical Image Digitizer Medical Image Hardcopy Device Medical Magnetic Tape Recorder
Medical Magnetic Tape Recorder Medical Neutron Radiation Therapy System Methamphetamine Test System
Microbial Growth Monitor Mobile X-Ray System Mobile X-Ray System
Motorized Three-Wheeled Vehicle Multi-Function Physical Therapy Table Nasopharyngeal Electrode
Natural Nonabsorbable Silk Surgical Suture Nd:YAG Laser for Capsulotomy and Iridotomy Needle Electrode
Neonatal Incubator Neonatal Phototherapy Unit Neonatal Transport Incubator
Neurovascular Embolization Device Newborn Screening Test System Nitric Oxide Administration Apparatus
Nitric Oxide Analyzer Nitrogen Dioxide Analyzer Nitrogen Gas Analyzer
Nitrous Oxide Gas Analyzer Nonabsorbable Polyamide Surgical Suture Nonabsorbable Polyamide Surgical Suture
Nonabsorbable Polypropylene Surgical Suture Noncontinuous Ventilator (IPPB) Nonelectrically Powered Fluid Injector
Nonelectrically Powered Fluid Injector Nonfetal Ultrasonic Monitor Non-Image-Intensified Fluoroscopic X-Ray System
Nonimplanted Electrical Continence Device Noninvasive Blood Pressure Measurement Nonrebreathing Valve
Nonroller-Type Cardiopulmonary Bypass Blood Pump Nose Prosthesis Nuclear Tomography System
Nystagmograph Ophthalmic Laser Ophthalmic Photocoagulator
Ophthalmoscope Opiate Test System Opthalmic Camera
Orthodontic Appliance and Accessories OTC Denture Cushion or Pad Oximeter
Oxygen Gas Analyzer Oxygen Gas Analyzer Partial Thromboplastin Time Tests
Partially Fabricated Denture Kit Patient Transducer and Electrode Cable Peak-Flow Meter for Spirometry
Pedicle Screw Spinal System Penile Rigidity Implant Perinatal Monitoring System
Perineometer Phacofragmentation System Photofluorographic X-Ray System
Physiological Signal Amplifier Picture Archiving and Communications System Pit and Fissure Sealant and Conditioner
Plasmodium Species Antigen Detection Assays Platelet Aggregometer Poly Surgical Suture
Polydioxanone Surgical Suture Polydioxanone Surgical Suture Polymethylmethacrylate Bone Cement
Polytetrafluoroethylene Surgical Suture Porcelain Powder for Clinical Use Porcelain Powder for Clinical Use
Porcelain Tooth Porcelain Tooth Portable Oxygen Generator
Portable Oxygen Generator Potassium Test System Power Traction Equipment
Powered Breast Pump Powered Emergency Ventilator Powered Muscle Stimulator
Powered Muscle Stimulator Powered Patient Transport Powered Suction Pump
Powered Wheelchair Powered Wheeled Stretcher Preformed Plastic Denture Tooth
Prothrombin Time Test Prothrombin Time Test Pulp Tester
Quality Control Material (Assayed and Unassayed) Radiation Therapy Simulation System Radiofrequency Signal Transmitter|Receiver
Radiofrequency Transponder System Radiographic Film Cassette Radiographic Film|Cassette Changer
Radionuclide Dose Calibrator Radionuclide Radiation Therapy System Remote Controlled Radionuclide Applicator
Remote Controlled Radionuclide Applicator System Remote Medication Management Reproductive Media and Supplements
Resin Tooth Bonding Agent Resin Tooth Bonding Agent Respiratory Gas Humidifier
Retinoscope Rigid Gas Permeable Contact Lens Rigid Gas Permeable Contact Lens Care
RNA Preanalytical Systems Roller-Type Cardiopulmonary Bypass Blood Pump Root Canal Filling Resin
Russell Viper Venom Reagent Scintillation (Gamma) Camera Self-Retaining Retractor for Neurosurgery
Shoulder Joint Prosthesis Shunt System Implantation Instrument Sodium Test System
Soft (Hydrophilic) Contact Lens Soft (Hydrophilic) Contact Lens Care Special Grade Wheelchair
Spinal Interlaminal Fixation Orthosis Spinal Intervertebral Body Fixation Orthosis Spring-Powered Jet Injector
Standup Wheelchair Steam Sterilizer Stereotaxic Instrument
Sterilization Process Indicator Sterilization Wrap Sterilization Wrap
Subperiosteal Implant Material Surgical Apparel Surgical Drape and Drape Accessories
Surgical Nerve Stimulator|Locator Syringe Needle Introducer Teething Ring
Teething Ring Telephone Electrocardiograph Transmitter|Receiver Temporary Crown and Bridge Resin
Therapeutic X-Ray Tube Housing Assembly Thrombin Time Test Thyroid Autoantibody Immunological Test System
Tinnitus Masker Tomographic X-Ray System Tooth Shade Resin Material
Topical Oxygen Chamber for Extremities Toxoplasma Gondiiserological Reagents Tracheal Tube
Tracheal|Bronchial Differential Ventilation Tube Tracheostomy Tube and Tube Cuff Transcutaneous Air Conduction Hearing Aid System
Transducer Signal Amplifier and Conditioner Transport Culture Medium Tympanostomy Tube
Ultrasonic Diathermy Ultrasonic Pulsed Doppler Imaging System Ultrasonic Pulsed Echo Imaging System
Ultrasonic Scaler Ultrasonic Transducer Ultrasound and Muscle Stimulator
Ultraviolet Activator for Polymerization Unscented Menstrual Pad Unscented Menstrual Tampon
Urea Nitrogen Test System Ureteral Stent Urinary Glucose Test System
Vaginal Pessary Vascular Embolization Device Ventricular Cannula
Water Purification System for Hemodialysis West Nile Virus Serological Reagents Wheelchair Elevator
Wheelchair Elevator Wound Dressing X-Ray Radiation Therapy System

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U.S. FDA Regulations:

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

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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