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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:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIO-BRIDGE SCIENCE, INC..
Classification:   IMPACTOR
Generic Device Name:   IMPACTOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIO-BRIDGE SCIENCE, INC..
Classification:   FILE
Generic Device Name:   TYPES OF FILES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIO-BRIDGE SCIENCE, INC..
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   TYPES OF KNIVES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIO-BRIDGE SCIENCE, INC..
Classification:   TREPHINE
Generic Device Name:   TREPHINE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIO-BRIDGE SCIENCE, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   TYPES OF SURGICAL ORTHOPEDIC SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIO-BRIDGE SCIENCE, INC..
Classification:   RONGEUR
Generic Device Name:   TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIO-BRIDGE SCIENCE, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIO-BRIDGE SCIENCE, INC..
Classification:   SET, HOLLOW MILL
Generic Device Name:   VARIOUS TYPES OF HOLLOW MILL SETS & BONE MILLS
Proprietary Device Name:   HOLLOW MILL SET
Registered Establishment Name:  R. QUETIN - DENTAL LEHRMATERIAL.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  WASHINGTON SURGICAL INTERNATIONAL.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  WASHINGTON SURGICAL INTERNATIONAL.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  WASHINGTON SURGICAL INTERNATIONAL.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  WASHINGTON SURGICAL INTERNATIONAL.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   SURGICAL BURR
Proprietary Device Name:   STRYKER, LINVATEC
Registered Establishment Name:  GRACE ENGINEERING CORP..
Classification:   TAP, BONE
Generic Device Name:   BONE TAP
Proprietary Device Name:   BIOMET
Registered Establishment Name:  GRACE ENGINEERING CORP..
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  MAXWELL INDUSTRY.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  MAXWELL INDUSTRY.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  MAXWELL INDUSTRY.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  MAXWELL INDUSTRY.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL POLYMER
Proprietary Device Name:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL,POLYMER, POROUS UNCEMENTED#ORTHOPEDIC
Registered Establishment Name:  GLOBAL MEDICAL COMPANY.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   ORTHOPEDIC TRACTION DEVICE
Proprietary Device Name:   TMR SPLINT
Registered Establishment Name:  TOTAL MOTION RESTORATION, LLC.
Classification:   COMPONENT, CAST
Generic Device Name:   CAST COMPONENT
Proprietary Device Name:   NEOMED CAST COMPONENT
Registered Establishment Name:  SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD..
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   VERTEBRAL BODY REPLACMENT
Proprietary Device Name:   ABBOTT SPINE, INC CODA SYSTEM
Registered Establishment Name:  KISCOMEDICA S.A..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  XINHUA SURGICAL INSTRUMENT CO. LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   TYPES OF SURGICAL ORTHOPEDIC SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  XINHUA SURGICAL INSTRUMENT CO. LTD..
Classification:   RONGEUR
Generic Device Name:   TYPE OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  XINHUA SURGICAL INSTRUMENT CO. LTD..
Classification:   TREPHINE
Generic Device Name:   TREPHINE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  XINHUA SURGICAL INSTRUMENT CO. LTD..
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  XINHUA SURGICAL INSTRUMENT CO. LTD..
Classification:   BIT, DRILL
Generic Device Name:   DRILL BITS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  XINHUA SURGICAL INSTRUMENT CO. LTD..
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   TYPES OF BURRS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  XINHUA SURGICAL INSTRUMENT CO. LTD..
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  XINHUA SURGICAL INSTRUMENT CO. LTD..
Classification:   IMPACTOR
Generic Device Name:   IMPACTOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  XINHUA SURGICAL INSTRUMENT CO. LTD..
Classification:   FILE
Generic Device Name:   TYPES OF FILES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  XINHUA SURGICAL INSTRUMENT CO. LTD..
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   TYPES OF KNIVES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  XINHUA SURGICAL INSTRUMENT CO. LTD..
Classification:   APPLIER, CERCLAGE
Generic Device Name:   CERCLAGE APPLIER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  XINHUA SURGICAL INSTRUMENT CO. LTD..
Classification:   BRACE, DRILL
Generic Device Name:   DRILL BRACE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  XINHUA SURGICAL INSTRUMENT CO. LTD..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Generic Device Name:   EXTERNAL FIXATOR
Proprietary Device Name:   TRAUMA-FIX EXTERNAL FIXATOR
Registered Establishment Name:  TREND MEDICAL, INC..
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   BENDING INSTRUMENTS
Proprietary Device Name:   BENDING INSTRUMENTS
Registered Establishment Name:  ULM-MEDIZINTECHNIK.
Classification:   WRENCH
Generic Device Name:   WRENCHES
Proprietary Device Name:   WRENCHES
Registered Establishment Name:  ULM-MEDIZINTECHNIK.
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTERS
Proprietary Device Name:   WIRE CUTTERS
Registered Establishment Name:  ULM-MEDIZINTECHNIK.

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Last Modified: 29 April 2006
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