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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:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   RONGEUR (MULTIPLE BRANDS)
Registered Establishment Name:  RICHARD WOLF MEDICAL INSTRUMENTS CORP..
Classification:   SPLINT, TRACTION
Generic Device Name:   SPLINT VARIOUS
Proprietary Device Name:   AMBU SPLINT
Registered Establishment Name:  AMBU INC..
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS TYPES OF STRIPPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   VARIOUS TYPES OF DYNAMOMETERS
Proprietary Device Name:   DYNAMOMETER
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   SPLINT, TRACTION
Generic Device Name:   FINGER BONE ABDUCTION INSTRUMENT
Proprietary Device Name:   FINGER BONE ABDUCTION INSTRUMENT
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   PROTRACTOR
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC PROTECTORS
Proprietary Device Name:   ORTHOPEDIC PROTECTOR
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   GAUGE, DEPTH
Generic Device Name:   ORTHOPEDIC DEPTH GAUGE
Proprietary Device Name:   ORTHOPEDIC DEPTH GAUGE
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   REAMER
Generic Device Name:   VARIOUS TYPES OF REAMERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   BROACH
Generic Device Name:   VARIOUS TYPES OF FEMORAL BROACHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF BURRS FOR ORTHOPEDIC USE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   IMPACTOR
Generic Device Name:   VARIOUS TYPES OF ORTH. IMPACTORS
Proprietary Device Name:   ORTHOPEDIC IMPACTOR
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS TYPES OF FEMORAL HEAD EXTRACTORS
Proprietary Device Name:   FEMORAL HEAD EXTRACTOR
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   STARTER, BONE SCREW
Generic Device Name:   VARIOUS TYPES OF BONE SCREW STARTERS FOR ORTHOPEDIC USE
Proprietary Device Name:   BONE SCREW STARTER
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   CORKSCREW
Generic Device Name:   CORKSCREW
Proprietary Device Name:   CORKSCREW
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   AWL
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC AWLS
Proprietary Device Name:   AWL
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   COMPRESSION INSTRUMENT
Proprietary Device Name:   COMPRESSION INSTRUMENT
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   SKID, BONE
Generic Device Name:   BONE SKID
Proprietary Device Name:   BONE SKID
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   PASSER
Generic Device Name:   PASSER
Proprietary Device Name:   SAW PASSER
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   DRIVER FOR FEMORAL SHAFT PROSTHESIS
Proprietary Device Name:   DRIVER FOR FEMORAL SHAFT PROSTHESIS
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   TEMPLATE
Generic Device Name:   TEMPLATE
Proprietary Device Name:   FEMORAL ANGLE CUTTING TEMPLATE
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   COUNTERSINK
Generic Device Name:   COUNTERSINKS, VARIOUS TYPES
Proprietary Device Name:   COUNTERSINK
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   PROSTHESIS, TENDON, PASSIVE
Generic Device Name:   VARIOUS TYPES OF TENDON PROSTHESES
Proprietary Device Name:   TENDON PROSTHESIS
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   WRENCH
Generic Device Name:   WRENCH
Proprietary Device Name:   WRENCH
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   TAMP
Generic Device Name:   WIRE TAMP
Proprietary Device Name:   WIRE TAMP
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF WIRE PASSERS
Proprietary Device Name:   ORTHOPEDIC WIRE PASSER
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   STAPLE DRIVER
Generic Device Name:   STAPLER
Proprietary Device Name:   ORTHOPEDIC STAPLER
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   PUSHER, SOCKET
Generic Device Name:   PUSHER
Proprietary Device Name:   SOCKET PUSHER
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS TYPES OF BENDING OR CONTOURING INSTRUMENTS FOR ORTHOPEDIC USE
Proprietary Device Name:   BENDING OR CONTOURING INSTRUMENTS
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   CRIMPER, PIN
Generic Device Name:   VARIOUS TYPES OF PIN CRIMPERS
Proprietary Device Name:   PIN CRIMPER
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS TYPES OF WIRE TWISTERS
Proprietary Device Name:   WIRE TWISTER
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   BENDER
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC BENDERS
Proprietary Device Name:   ORTHOPEDIC BENDER
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS TYPES OF SCREWDRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   BRACE, DRILL
Generic Device Name:   VARIOUS TYPES
Proprietary Device Name:   ORTHOPEDIC BRACE DRILL
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Generic Device Name:   VARIOUS TYPES OF PROXIMAL FEMORAL FIXATION DEVICES
Proprietary Device Name:   PROXIMAL FEMORAL
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
Generic Device Name:   VARIOUS TYPES OF CONDYLAR PLATES
Proprietary Device Name:   CONDYLAR PLATE, IMPLANT, FIXATION DEVICE
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   BONE NAIL
Proprietary Device Name:   BONE NAIL
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   CAP, BONE
Generic Device Name:   BONE CAPS
Proprietary Device Name:   BONE CAP
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   CEMENT MIXER
Proprietary Device Name:   CEMENT MIXER
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.

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Last Modified: 29 April 2006
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