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US Food and Drug Administration (FDA) - Orthopedic Devices Registration

FDA Registered Orthopedic Devices - Updated May 2006

What Is Medical Device Listing?

Most medical device establishments required to register with FDA must also identify to FDA the devices they have in commercial distribution including devices produced exclusively for export. This process is known as medical device listing and is a means of keeping FDA advised of the generic category(s) of devices an establishment is manufacturing or marketing.
FDA Devices
FDA Devices
FDA Devices
FDA Devices


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Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  LAFAYETTE INSTRUMENT CO., INC..
Classification:   DISPENSER, CEMENT
Generic Device Name:   DISPENSER, CEMENT
Proprietary Device Name:   HIGH PRESSURE INJECTION SYRINGE
Registered Establishment Name:  COOK, INC..
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   VARIOUS CEMENT MIXERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS.
Classification:   DISPENSER, CEMENT
Generic Device Name:   VARIOUS TYPES & STYLES OF CEMENT DISPENSERS
Proprietary Device Name:   ZIMMER CEMENT DISPENSING SYSTEMS (MULTIPLE)
Registered Establishment Name:  ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS.
Classification:   EVACUATOR, VAPOR, CEMENT MONOMER
Generic Device Name:   VARIOUS TYPES OF CEMENT MONOMER EVACUATOR SYSTEMS
Proprietary Device Name:   ZIMMER VACUUME PUMPS SYSTEMS
Registered Establishment Name:  ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS.
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   VARIOUS TYPES AND SIZES OF PROSTHESIS DRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   EVACUATOR, VAPOR, CEMENT MONOMER
Generic Device Name:   BONE CEMENT MIXING BOWL
Proprietary Device Name:   SUPER BOWL
Registered Establishment Name:  ZIMMER, INC..
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF STRAIGHT AND CURVED SCISSORS (OPERATING, DISSECTING)
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS TYPES OF SCREWDRIVERS AND BITS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   MISCELLANEOUS SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES AND SIZES OF STAPLES AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS TYPES AND SIZES OF SURGICAL STRIPPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   TAMP
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   TAP, BONE
Generic Device Name:   VARIOUS SIZES OF BONE SCREW TAPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   TEMPLATE
Generic Device Name:   VARIOUS TYPES OF TEMPLATES AND GAUGE SETS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES AND SIZES OF NEEDLE HOLDERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   TREPHINE
Generic Device Name:   TREPHINES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   TUBE, CEMENT VENTILATION
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   TWISTER, WIRE
Generic Device Name:   WIRE TWISTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   WIRE, SURGICAL
Generic Device Name:   VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE FIXATION WIRES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   WRENCH
Generic Device Name:   VARIOUS TYPES AND SIZES OF WRENCHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TYPES AND SIZES OF DRILL BITS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   FIXATION ACCESSORY
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR UNCEMENTED PROSTHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   ROTATING HINGED KNEES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   APPLIER, CERCLAGE
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   BENDER
Generic Device Name:   BENDING IRONS AND RODS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   BONE CEMENT
Generic Device Name:   BONE CEMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   BRACE, DRILL
Generic Device Name:   VARIOUS BRACES FOR REAMERS AND DRILLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   BROACH
Generic Device Name:   BROACH
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES AND SIZES OF BURRS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   CALIPER
Generic Device Name:   CALIPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   DISPENSER, CEMENT
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..

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Last Modified: 29 April 2006
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