Biomaterials.info

powered by FreeFind

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


First Page Previous Page Next Page Last Page
Classification:   RONGEUR
Generic Device Name:   BONE RONGEURS DOUBLE/ACTION AND DOUBLE ACTION RIB SHEARS
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  KUHN MEDIZINTECHNIK.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   OVERDOOR TRACTION
Proprietary Device Name:   APPARATUS, TRACTION, NON-POWERED
Registered Establishment Name:  APEX MEDICAL CORP..
Classification:   PIN, FIXATION, SMOOTH, METALLIC
Generic Device Name:   FLATFOOT IMPLANT
Proprietary Device Name:   BIOPRO SUBTALAR IMPLANT
Registered Establishment Name:  BIOPRO, INC..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   TIBIAL NAIL
Proprietary Device Name:   WUJIN # 3 TIBIAL NAIL
Registered Establishment Name:  BIOPRO, INC..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   FIXATION PIN
Proprietary Device Name:   DIGITAL COMPRESSION SCREW
Registered Establishment Name:  BIOPRO, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF SURGICAL INSTRUMENTS
Proprietary Device Name:   BIOPRO SURGICAL INSTRUMENTS
Registered Establishment Name:  BIOPRO, INC..
Classification:   PROSTHESIS, HIP, FEMORAL, RESURFACING
Generic Device Name:   FEMORAL RESURFACING COMPONENT
Proprietary Device Name:   BIOPRO TARA FEMORAL RESURFACING COMPONENT
Registered Establishment Name:  BIOPRO, INC..
Classification:   PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
Generic Device Name:   TOTAL ELBOW REPLACEMENT
Proprietary Device Name:   BIOPRO TOTAL ELBOW SYSTEM
Registered Establishment Name:  BIOPRO, INC..
Classification:   PROSTHESIS, TOE, HEMI-, PHALANGEAL
Generic Device Name:   TOE JOINT
Proprietary Device Name:   BIOPRO HEMI MP JOINT
Registered Establishment Name:  BIOPRO, INC..
Classification:   PROSTHESIS, WRIST, CARPAL TRAPEZIUM
Generic Device Name:   THUMB JOINT
Proprietary Device Name:   BIOPRO MULTIPLE THUMB IMPLANTS
Registered Establishment Name:  BIOPRO, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   HIP REPLACEMENT
Proprietary Device Name:   BIOPRO PSL TOTAL HIP SYSTEM
Registered Establishment Name:  BIOPRO, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   REVERSE PLIERS
Proprietary Device Name:   WASHER REMOVER
Registered Establishment Name:  SCIENTIFIC SPINAL LTD..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   CANCELLOUS BONE SCREW
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENTIFIC SPINAL LTD..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   1/4" STAINLESS STEEL RATCHETED SPINAL ROD (HARRINGTON ROD)
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENTIFIC SPINAL LTD..
Classification:   WASHER, BOLT NUT
Generic Device Name:   HARRINGTON C-WASHER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENTIFIC SPINAL LTD..
Classification:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   RODSLEEVE
Proprietary Device Name:   EDWARDS ROO SLEEVE, VARIOUS
Registered Establishment Name:  SCIENTIFIC SPINAL LTD..
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   CAST SPREADER
Proprietary Device Name:   CAST SPREADER
Registered Establishment Name:  DARCO INTERNATIONAL, INC..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DARCO INTERNATIONAL, INC..
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS TYPES OF SCREWDRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DARCO INTERNATIONAL, INC..
Classification:   STARTER, BONE SCREW
Generic Device Name:   VARIOUS TYPES OF SCREWDRIVER BITS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DARCO INTERNATIONAL, INC..
Classification:   GAUGE, DEPTH
Generic Device Name:   DEPTH GUAGE
Proprietary Device Name:   DEPTH GUAGE
Registered Establishment Name:  DARCO INTERNATIONAL, INC..
Classification:   MONITOR, PRESSURE, INTRACOMPARTMENTAL
Generic Device Name:   COMPARTMENTAL PRESSURE MONITORING SYSTEM
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH.
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   EXTERNAL FIXATION DEVIVE WITH THREADED THREADED FIXATION PINS
Proprietary Device Name:   STABLELOC EXTERNAL FIXATION SYSTEM
Registered Establishment Name:  ACUMED LLC.
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   SMALL BONE FIXATOR
Proprietary Device Name:   SMALL BONE FIXATOR OR SBF
Registered Establishment Name:  ACUMED LLC.
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   SUTURE ANCHOR
Proprietary Device Name:   ACUMED SUTURE ANCHOR
Registered Establishment Name:  ACUMED LLC.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   BONE GRAFT INSRUMENTS
Proprietary Device Name:   ACUMED BONE GRAFT SYSTEM
Registered Establishment Name:  ACUMED LLC.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   FIXATION PIN
Proprietary Device Name:   TENSION BAND PIN
Registered Establishment Name:  ACUMED LLC.
Classification:   PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Generic Device Name:   MODULAR SHOULDER SYSTEM
Proprietary Device Name:   POLARUS MODULAR SHOULDER SYSTEM
Registered Establishment Name:  ACUMED LLC.
Classification:   CERCLAGE, FIXATION
Generic Device Name:   CERLAGE,FIXATION (WIRE & CABLE)
Proprietary Device Name:   OSTEO-CLAGE CERCLAGE CABLE SYSTEM
Registered Establishment Name:  ACUMED LLC.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE FIXATION SCREW, ACUTRAK, ACUTRAIL PLUS, EXTREMITY, FUSION, MINI ACUTRAK
Proprietary Device Name:   ACUTRAK PLUS
Registered Establishment Name:  ACUMED LLC.
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   ULNA, RADIUS, FIBULA ROD
Proprietary Device Name:   ACUMED SMALL BONE LOCKING ROD SYSTEM II
Registered Establishment Name:  ACUMED LLC.
Classification:   PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
Generic Device Name:   PROTHESIS, ELBOW JOINT RADIAL HEAD
Proprietary Device Name:   ACUMED ANATOMIC RADIAL HEAD SYSTEM
Registered Establishment Name:  ACUMED LLC.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   SINGLE,MULTIPLE COMPONENT BONE FIXATION APPLIANCE AND ACCESSORIES
Proprietary Device Name:   ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM
Registered Establishment Name:  ACUMED LLC.
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   BONE SCREW & BONE SCREW INSERTER
Proprietary Device Name:   IN-FAST BONE SCREW SYSTEM
Registered Establishment Name:  AMERICAN MEDICAL SYSTEMS, INC..
Classification:   TEMPLATE
Generic Device Name:   WOUND MEASUREMENT TRACING GRID
Proprietary Device Name:   VISITRAK GRID
Registered Establishment Name:  SMITH AND NEPHEW MEDICAL LTD..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS SIZES OF BONE SCREWS
Proprietary Device Name:   SCREW, FIXATION, BONE
Registered Establishment Name:  REDA INSTRUMENTE GMBH.
Classification:   WIRE, SURGICAL
Generic Device Name:   WIRE, SURGICAL
Proprietary Device Name:   WIRE, SURGICAL
Registered Establishment Name:  REDA INSTRUMENTE GMBH.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   APPARATUS, TRACTION, NON-POWERED
Proprietary Device Name:   REAL-EASE
Registered Establishment Name:  KENSHIN TRADING CORP..
Classification:   REAMER
Generic Device Name:   SURGICAL OR PROSTHETIC INSTRUMENT
Proprietary Device Name:   REAMER
Registered Establishment Name:  NOBEL BIOCARE USA, LLC.
Classification:   IMPACTOR
Generic Device Name:   SURGICAL INSTRUMENT
Proprietary Device Name:   IMPACTOR
Registered Establishment Name:  NOBEL BIOCARE USA, LLC.

First Page Previous Page Next Page Last Page




Last Modified: 29 April 2006
http://www.biomaterials.info
Sitemap
Link | Link | Link | Link | Link | Link | Link | Link