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HomeMedical DevicesMedical Devices Master Files (MAF) › Medical Devices Master Files Examples

Medical Devices Master Files Examples

The following are examples of MAFs filed with the U.S. Food and drug Administration (U.S. FDA).

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

3% Sodium Hyaluronate ABS Cycolac Absorbable Dusting Powder
Acellular, Collagen-Based Material Acetabular Cup Acetyltri-N-Butyl Citrate
Acid Detergent Acrylic Acrylic Latex Coating
Acrylonitrite Butadiene Styrene Adhesives Aerosol Solution
Alumina Bioceramic Hip Ball Joints Alumina Ceramic Alumina Femoral Head
Analyser Antibiotic Susceptibility Discs Antimicrobial Coatings
Antimicrobial Compound Antimicrobial Products Antimicrobial Silver
Antioxidant Polyethylene Apheresis Immunoadsorption Column Applied Liquid Silicone Rubber
Arcom Polyethylene Argon Laser Arrhythmia Algorithm Software
Artho-Phthalaldehyde Articular Surface Replacement Askina Hydrocolloid Wound Dressings
Auto Injector Balloon-Expandable Stent Bard Septal Occlusion System
Barrier Resin Barrier Silicone Dispersion Battery for Implantable Pacemakers
Battery System Bayblend Beco Depth Filter Sheets
Bemis Burette Chamber Beta Tri-Calcium Phosphate Beta-Cath 3.5.F System
Beta-Tricalcium Phosphate BHC Composite Bioabsorbable Polymer Composites
Bio-Actie Membrane Bioactive Orlon Biocardia Helical Infusion Catheter
Bioceramic Hip Joint Balls Biocompatibility Test Reports Biocompatible, Lubricious Coatings
Biodegradable Polymer Excipients Bioerodible Polymeric Materials Biological Indicator
Biostable Elastomer Biosteon Composite Bistim Module
Blue PMMA Monofilament Blue Polypropylene Monofilament Bone Cement
Bone Graft Material Bore Fluids Bovine Calf Serum
Buffer Formulation CABANA Trial Capsular Tension Ring
Carboxymethylcellulose Sodium Carmeda Bioactive Surface Cast Polyurethane Film
Catheter Introducer System Catheter Materials Catheter Systems
CCP Petrothene Celanex Polybutylene Terephthalate Celcon Acetal Copolymer
Cell Culture Media Cell Culture Production Facility Cell Line Production Process
Cellulosic Membrane Materials Centering Catheter Centocor Autoinjector
Ceramic Cups and Inserts Ceramic Femoral Heads Ceramic Hip Heads
Ceramic Hip Stem Head Ceramic Modular Heads Ceramic Orthopaedic Components
Chemical Throughput Indicator Chorionic Villus Sampling Catheter Chronothane T
Cleaning Solution Clear Polymethlemethacrylate Clinical Study
Clinical Study Closed Loop Investigational PDN Coating for Medical Device Implants
Coating Formulation Coating Reagents Coatings
Coating Technology Coaxial Catheters Cobe Bct
Collagen Collagen Ceramic Composite Collagen Membrane Component
Collagen Sealant Component Analyzer Composition and Design
Composition and Processing Composition and Toxicity Composition of Adhesives
Composition of Aroset Products Composition of Fragrances Composition of Hycar
Composition of Latex Composition of Lustran Composition of Noryl Formulations
Composition of Packaging Materials Composition of Resins Composition of Sclairfilms
Composition of the Cervical Cap Compression Sleeve Manufacturing Concentrated Acid Detergent
Concentrated Neutral Detergent Contact Lens Blanks Contact Lens Material
Contact Lens Omafilcon-A Containers and Closures Contract Packager
Contract Sterilization Site Control Information Copper Oxide
Coracoclavicular Cerclage Device Corneal Ring Segments Coronary Afterloader Cr
Coronary Bifurcation Stent System Covacoat with Silver CP Stent
Crofilcon A Contact Lenses Cryopreservation Media Cycolac
Cystatin C Cytofusion and Cytoporation Media Data & Information
Decontamination Formulation Delcath Double Balloon Catheter Delrin Acetal Resins
Denture Cushions Deodorizing Powder Derma Vax
Detergents Dexamethasone Sodium Phosphate Diagnostic Ultrasound Transducers
Digital X-Ray Technical Information Diphoterine Disinfectant
Disinfectant_Sterilant Product Dispersions for Latex Applications Disposable Auto Injector
Disposable Auto Injector Double Cone Coil Drug Delivery Systems
Drug-Eluting Stent Duraflo Treatment Elastomer
Elastomeric Components Alternative Electron Beam Facility Electronic Controller
Endoscopic Control System Engineering Drawings Enternal Ambulatory Infusion Pump
Enzymatic Cleaner Epicard Auto-Injector Epoxy
Ethgylene Vinyl Acetate Copolymers ETR Elastomer Excimer Laser System
Expanded Surface Roller Bottle Eye Drops Eye Fixation Device
Femoral Heads Femoral Heads Fibernet Embolic Protection System
Fibrous Collagen Filled Methacrylate Terpolymer Filling Operation
Film for Medical Wound Dressings Film Grade Resin Filter Material
Filter Membrane Filters and Filter Cartridges Flat Interface Nerve Electrode
Flavorings Flexible PVC Parental Bags Fluorochemical Ester
Fluoroplate Powder Coating Fluoroptic Thermometer Formaldehyde Detection Data
Formulation for Fragrances Formulation for Plastic Alloy Formulation for PolyHEMA Material
Formulation for Silicone Tubing Formulation for W & H Service Oil Forton Polyphenylene Sulfide
Forusorb Biodegradeable Polymers Freezgel Chemical Compounds Galxyl Patylene
Gamma Irradiation Gas Plasma Sterilization Gaseous Sterilization System
Gelatin Microcarrier Gel-Filled Mammary Implants Genechip Arrays
Genetics and Inflammatory Markers Glutaraldehyde Guidewire
Gur and Ghr Polyethylenes Ha & Titanium Coating HDL Precipitation Reagent
Healos Bone Graft Heart Valve Heart-Valve
Heat Cured Elastomer Dispersions Heatmarker Time-Temperature Heavy Duty Alkaline Detergent
Heparin Coatings Hepatitis A Assay Hexamoll Dinch
HF Action High Consistency Rubber High Consistency Silicone Elastomer
High Density Polyethylene High Purity Alpha Alumina High Purity Aluminum Oxide
High Strength Firm Gel System Hip Ball Honeycomb Sponge
Hostaform Acetal Copolymer Hot Stamp Ink Ribbons Human Papillomavirus DNA Typing Kit
Hyalectin-F Hyaluronate Gel Implants Hyaluronic Acid Powder
Hydrocolloid Adhesive Formulation Hydrogel Adhesive Hydrogel Materials
Hydrogen Peroxide Hydrophilic Coating Hydroxyapatite Coated Products
Hydroxyapatite Coatings Hydroxylapatite Hydroxylapatite Coatings
Hydroxylapatite Powder Hydroxypatite Coatings Immunoisolation Device
Implant Fixation Technology Process Implantable Access System Infusion System
Injection Catheter System Instrument Lubricant Insulin Infuser
Insulin Infusion Pump Intraocular Fluid Intraocular Lens Material
Ionbond's Titanium Nitride Coating Irradation System Irradiation Facility
Irradiation Safety System Irradiation System Isobutyl Tuads
Isobutyl Zimate Isoplast 2531 Polyurethane Laser Shot
Laser System Laser System Lea Contraceptive
Leukoreduction Filter Lid Film for Contact Lenses Light Saber Collimator
Liquid Embolization Device Liquid Sanitizer Liquid Silicone Elastomer
Liquid Silicone Rubber Liquid Tissue Cultrue Media Lithium Ion Secondary Batteries
Lithium_Iodine Pacemaker Batteries M3 Media Material Biocompatibility Reports
Material Safety Data Sheets Material Testing Compendium Medical Adhesive Silicone
Medical Device Packaging Medical Device Reprocessing Medical Grade PVC
Medical Grade Tubing Medisorb Polymers Membranes_Gels
Methafilcon A Methoxsalen Capsules and Lotions Microbial Cellulose
Microfill Operating Instructions Microporous Urethane Mobility Scooter Controller
Modified Eagle Media Monodonal Antibody Conjugation Monomers and Polymers
Morcher Capsular Tension Ring Motor Controller MRI Coil
Multi-Modality Monitoring System Multipolymer Resin Emulsions Multipolymer Resin Solution
Nema Lithrotipsy Hypertension Study Neurostimulation System Magnetic Navigation System
Non-Photo Polymers Non-Woven Fabric Biopolymers Optical Buttons
Orthopaedic Ceramic Orthopaedic Hip Implants Ortho-Phthalaldehyde
Orthovita Corticocancellous Chips Osprovit Hydroxyapatite Coating Osteophilic Coating
Oxidized Regenerated Cellulose Oxygen Absorbers Ingredients Packaging Materials
Pallflex Filter Material Palmaz Balloon-Expandable XL Stent Parvovirus B19 Assay
Parylast Passivation Process PC Colorants
PDDS Clinical Device Pellethane Tubing Pen Device for Teriparatide
Peracetic Acid Solution 5% Peracetic Acid Test Strip Percutaneous Catheter Injector
Percuteous Infection Control Device Perfluoroalkyl Polymers Perfluoroperhydrophenanthrene
PFS Autoinjector Pharmaceutical Production Facility Photodynamic Diagnosis System
Phycomer E01 Pilyethylene Terephthalate Pinnacle Shells
Pittsburgh Cell Delivery Cannula Pkyrolytic Carbon Plasma Sprayed Coatings
Plastic Material Plexiglas Polyactive
Polybutylene Terephthalate Polycarbonate Polycarbonate Plastic Resin
Polycarbonate Polyurethane Polycarbonate Resin Polycarbonate Urethanes
Polycarbonate-Polyurethanes Polyester Film Products Polyester Production Facilities
Polyester Urethane Polyesters Polyether Polyurethane
Polyethylene Polyglycolide Polyhexamethylene Biquanide
Polymers Polymethylmethacrylate CQ UV Polyox Water Soluable Resins
Polypropylene Polypropylene Resins Polysulfone
Polytef Paste Polyurethane Polyurethane Film Platilon
Polyurethane Form Polyurethane Membrane Polyurethane Raw Materials
Polyvinyl Chloride Resins Polyzene-F Porex Porous Hydrophobic Plug
Porocoats Products Porous Biomaterials Porous Callagen Matrix
Porous Coating Technique Porous Pad Porous Polyethylene Plug
Porous Tantalum Powder For Coating Powder for Embolization
Powerchair Control System Powerchair Motor Controller Pressure Assisted Delivery Devices
Primer Solutions Process Indicator Device Production of Liquid Crystals
Pronova Calcium Alginate Protein A Protein-Free Medium
PS Gel Serum Separating Sealant PTFE Coated Guide Wires PTFE Covered Stent System
PTFE Fluorocarbon Resins Purcoat Coating Pure Pyrolyic Carbon
Qiocompatibility Test Reports Quadrajet Surgical Injector Device Quality Assurance Manual
Quality Management System Radiofrequency Lesion Generator Raw Material Optical Buttons
Reagents Red Cell Cad Wafer Reports for DC Motor Controllers
Reprocessing Protocol Resdel Epoxy Tubing Research Procedures
Resins Responsive Silicone Gel Reuse Procedure Manual
Rings, Mesh and Screws Rotaglide Lubricant Rough Porous Coating
RPMI Medium RTV Adhesive RTV Silicone Elastomer
Rubber Closure Formulation Rubber Latex-Free Formulation Rubber Plunger Tips
Saline-Fill Mammary Implant Scooter Controller Sealant
Second Harmonic Feature Segmented Polyurethane Segmented Polyurethane
Serofine Needles Serum Separating Sealant Sham Coil
Shelhigh Percardial Patches Silastic Ribbon Silastol Products
Silica Gel Fiber Silicone Adhesive Silicone Chemistry
Silicone Coating Silicone Compound Silicone Devices Test Reports
Silicone Dispersion Silicone Elastomer Silicone Elastomer Dispersion
Silicone Fluid Silicone Formulations Silicone Gel
Silicone Gum Polymer Silicone High Strength Gel Silicone Hydrogel Soft Contact Lens
Silicone Ink Silicone Material Silicone Material for Vial Stoppers
Silicone Membrane Silicone Oil Silicone Polymer
Silicone Primer Silicone Rtv Elastomer Silicone Rubber Compound
Silicone Rubber Over Molding Silicone Sheeting Smoke Evacuation System
Sodium Hyaluraonate Sodium Hyaluronate Powder Sodium Hyauronate
Soft PVC Granules Soluble Collagen Solutions Facility
Soybean Agglutinin Specifications for Plexiglas Specifications Material and Testing
Springsteel Wire Stainless and Heat Resisting Steels Stainless Steel
Stemline T-Cell Expansion Medium Stent Systems Sterile Water for Inhalation
Sterilization Facility Sterilization Indicators Sterilization Process
Sterilization Process Indicators Sulfurhexafluoride Gas Summary Information: Wound Dressing
Summit Stem Surface Silicone on Rubber Closures Syed Brachytherapy Catheter
Synchromed Infusion System Syringe Filter Syringe Safety Needle Guard
Syringe System Syringes Tangent Allograft
Tempo Inhaler Testing Compendium Texins
Thermal Transfer Ink Ribbons Thermoplastic Compounds Thermoplastic Polyurethane
Thermoplastic Resins Theromplastic Polyurethane Tissue Adhesive
Tissue Culture Media Titanium Plasma Spray Coating Top Coat
Toxicity and Mutagenicity Studies Toxicity Test Data Toxicity Testing
T-Prk Excimer Laser Trafermin Bulk Drug Substance Transesophageal Probe
Transvascular Transaccess Trigrid Delivery System Trioctyl Trimellitate
Trucount Absolute Count Beads Type I Sodium Hyaluronate Type II Sodium Hyaluronate
Tyrosine-Derived Polycarbonates Ultra High Purity Silicone Fluid Ultramid B 3 S
Unicote Glove Coating Polymer Urethane Coating UV-Absorbing Cast Acrylic
Vaginal Applicators Vaginal Pack Safety Testing Veriva Polyphenylsulfone
Vial Stoppers Vibrating Mesh Aerosolizer Vinyl Compounds
Vinyl Label Stock Viperslide Atherectomy Lubricant Wallstent Monorail Endoprosthesis
Welding Agent Wound Therapy Device YAG Laser System
YAG Medical System Zangen Coil Zenith Endovascular Graft
Zirconia Ceramic Heads Zirconia Ceramics Zirconia-Coated Zirconium
ZTA Ceramic Material Zyranox Zirconia Femoral Heads

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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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