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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:   CRIMPER, PIN
Generic Device Name:   VARIOUS TYPES OF PIN CRIMPERS
Proprietary Device Name:   MULTIPLE PRIVATE LABEL
Registered Establishment Name:  RAIMUND WENZLER GMBH, INSTRUMENTEN-MANUFAKTUR.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARL TEUFEL GMBH & CO..
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES OF PROBES USED IN OPHTHALMOLOGY
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARL TEUFEL GMBH & CO..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   NEEDLE HOLDERS FOR HAND SURGERY
Proprietary Device Name:   INSTO NEEDLE HOLDERS, 130-150 MM
Registered Establishment Name:  GUENTER STOFFEL MEDIZINTECHNIK GMBH.
Classification:   RONGEUR
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED GMBH.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   CAST REMOVAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED GMBH.
Classification:   IMPACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED GMBH.
Classification:   PROBE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED GMBH.
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED GMBH.
Classification:   FORK
Generic Device Name:   FORK
Proprietary Device Name:   FORK
Registered Establishment Name:  INSTRUMED GMBH.
Classification:   PASSER
Generic Device Name:   PASSER
Proprietary Device Name:   PASSER
Registered Establishment Name:  INSTRUMED GMBH.
Classification:   BIT, DRILL
Generic Device Name:   BIT, DRILL
Proprietary Device Name:   BIT, DRILL
Registered Establishment Name:  INSTRUMED GMBH.
Classification:   AWL
Generic Device Name:   VARIOUS TYPES OF AWLS
Proprietary Device Name:   AWL
Registered Establishment Name:  PAUL STENGELIN KG..
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS TYPES OF EXTRACTORS
Proprietary Device Name:   EXTRACTOR
Registered Establishment Name:  PAUL STENGELIN KG..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCHREIBER GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   CHARNLEY CUP TRIMMING SCISSORS
Proprietary Device Name:   CHARNLEY CUP TRIMMING SCISSORS
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   ARTHROSCOPE
Generic Device Name:   SYSTEM 80 ARTHROSCOPE SET
Proprietary Device Name:   SYSTEM 80 ARTHROSCOPE SET
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   SPLINT, TRACTION
Generic Device Name:   VARIOUS TYPES OF TRACTION SPLINTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   *V* VARIOUS TYPES OF TRACTION ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   BROACH
Generic Device Name:   CHARNLEY BROACH
Proprietary Device Name:   CHARNLEY BROACH
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   PATON BURR
Proprietary Device Name:   PATON BURR
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   RONGEUR
Generic Device Name:   CHARNLEY ACETABULAR SCRAPER
Proprietary Device Name:   CHARNLEY ACETABULAR SCRAPER
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   EXTRACTOR
Generic Device Name:   WROBLEWSKI FRACTURED PROSTHESIS REMOVER KIT
Proprietary Device Name:   WROBLEWSKI FRACTURED PROSTHESIS REMOVER KIT
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   STARTER, BONE SCREW
Generic Device Name:   SMITH PETERSON STARTER
Proprietary Device Name:   SMITH PETERSON STARTER
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   CORKSCREW
Generic Device Name:   WROBLEWSKI FEMORAL CEMENT REMOVER
Proprietary Device Name:   WROBLEWSKI FEMORAL CEMENT REMOVER
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   TREPHINE
Generic Device Name:   CHARNLEY REVISION TREPHINE AND CLEANER
Proprietary Device Name:   CHARNLEY REVISION TREPHINE AND CLEANER
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   PUNCH, FEMORAL NECK
Generic Device Name:   CHARNLEY FEMORAL NECK PUNCH
Proprietary Device Name:   CHARNLEY FEMORAL NECK PUNCH
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES OF PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   FORK
Generic Device Name:   CHARNLEY TROCHANTER HOLDERS
Proprietary Device Name:   CHARNLEY TROCHANTER HOLDERS
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   HOLDER, NEEDLE; ORTHOPEDIC
Proprietary Device Name:   CHARNLEY TROCHANTER HOLDERS
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   BRACE, DRILL
Generic Device Name:   CHARNLEY LIGHTWEIGHT BRACE
Proprietary Device Name:   CHARNLEY LIGHTWEIGHT BRACE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   FIXATION ACCESSORY
Generic Device Name:   VARIOUS TYPES OF ACCESSORIES TO EXTERNAL FIXATION SYSTEM
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   TENOTOMY KNIFE
Proprietary Device Name:   TENOTOMY KNIFE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   SKID, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, UNICONDYLER, METAL/POLYMER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   WIRE, SURGICAL
Generic Device Name:   WIRE
Proprietary Device Name:   CHARNLEY WIRE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   PUSHER, SOCKET
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC SOCKET PUSHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..

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Last Modified: 29 April 2006
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