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:   BRACE, DRILL
Generic Device Name:   STEP DRILL
Proprietary Device Name:   BRACE, DRILL
Registered Establishment Name:  O.M.T. OBERFLACHEN-UND MATERIALTECHNOLOGIE GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   ADAPTER FOR OSW-/OSS-SCREW
Proprietary Device Name:   SCREWDRIVER
Registered Establishment Name:  O.M.T. OBERFLACHEN-UND MATERIALTECHNOLOGIE GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   SCARF BONE CLAMP
Proprietary Device Name:   BONE HOLDING & REPOSITION FORCEPS
Registered Establishment Name:  O.M.T. OBERFLACHEN-UND MATERIALTECHNOLOGIE GMBH.
Classification:   PIN, FIXATION, SMOOTH, METALLIC
Generic Device Name:   BIOABSORBABLE BONE FIXATION PINS AND SCREWS
Proprietary Device Name:   RE-FIX BIODEGRADABLE PINS AND SCREWS
Registered Establishment Name:  XTREMI-T, LLC.
Classification:   DISPENSER, CEMENT
Generic Device Name:   CEMENT MIXER AND APPLICATION SYSTEM
Proprietary Device Name:   BO-CE-MIX
Registered Establishment Name:  BIDOIA, S.A.S..
Classification:   AWL
Generic Device Name:   VARIOUS AWLS
Proprietary Device Name:   N-GUIDE
Registered Establishment Name:  N SPINE, INC..
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   VARIOUS ARTHROSCOPIC ACCESSORIES
Proprietary Device Name:   N-GUIDE
Registered Establishment Name:  N SPINE, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS MODELS OF NON-POWERED TRACTION APPARATUS
Proprietary Device Name:   MUTLIPLE
Registered Establishment Name:  BESTCARE INT'L LTD..
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   STERILE SOFT TISSUE FIXATION DEVICES AND INSTRUMENTATION
Proprietary Device Name:   SCANDIUS ABSORBABLE ACL FIXATION SYSTEM
Registered Establishment Name:  SCANDIUS BIOMEDICAL, INC..
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   STERILE SOFT TISSUE FIXATION DEVICES AND INSTRUMENTATION
Proprietary Device Name:   SCANDIUS NONABSORBABLE ACL FIXATION SYSTEM
Registered Establishment Name:  SCANDIUS BIOMEDICAL, INC..
Classification:   COMPONENT, CAST
Generic Device Name:   ORTHOPEDIC CASTING TAPE, DUST COLLECTOR TAPE
Proprietary Device Name:   EZ-CAST
Registered Establishment Name:  RTS INTERNATIONAL, LLC.
Classification:   COMPONENT, CAST
Generic Device Name:   PLASTER OF BANDAGE, POP, CAST BANDAGE, CAST COMPONENT
Proprietary Device Name:   SPT PB
Registered Establishment Name:  SPT TECHNOLOGY, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   CERVICAL SPINAL IMPLANT
Proprietary Device Name:   OCCIPITAL CERVICAL LOOP
Registered Establishment Name:  INTEGRA LIFESCIENCES CORPORATION.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INTEGRA LIFESCIENCES CORPORATION.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS SIZES AND STYLES FOR DRILL BITS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INTEGRA LIFESCIENCES CORPORATION.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS BONE PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INTEGRA LIFESCIENCES CORPORATION.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ENDO-INSTRUMENTS MEDIZINTECHNIK GMBH.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   OVERHEAD TRACTION SET
Proprietary Device Name:   APPARATUS, TRACTION, NON-POWERED
Registered Establishment Name:  MOUNTAIN PROPERTIES, LTD., THE MOBILITY AID CO..
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES OF PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STEMA MEDIZINTECHNIK GMBH.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   APEX SPINE SYSTEM
Registered Establishment Name:  SPINECRAFT, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  IKAS ASSOCIATES.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  IKAS ASSOCIATES.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  IKAS ASSOCIATES.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER
Registered Establishment Name:  IKAS ASSOCIATES.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE VOID FILLER
Proprietary Device Name:   COLLOSS E
Registered Establishment Name:  OSSACUR AG.
Classification:   IMPACTOR
Generic Device Name:   VARIOUS TYPES OF STERILE AND NON-STERILE IMPACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DISC ORTHOPAEDIC TECHNOLOGIES, INC..
Classification:   CALIPER
Generic Device Name:   HIP MEASURING DEVICE
Proprietary Device Name:   CALIPER
Registered Establishment Name:  KOVA EQUIPMENT, LTD..
Classification:   TEMPLATE
Generic Device Name:   ANATOMICAL MODELS
Proprietary Device Name:   PROTOMED CUSTOM ANATOMICAL MODELS
Registered Establishment Name:  PROTOMED, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  FIANIM ENTERPRISES.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  FIANIM ENTERPRISES.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  FIANIM ENTERPRISES.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  FIANIM ENTERPRISES.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   HOLDER, NEEDLE; ORTHOPEDIC
Proprietary Device Name:   HOLDER, NEEDLE; ORTHOPEDIC
Registered Establishment Name:  SURGIMEN INSTRUMENTS.
Classification:   RONGEUR
Generic Device Name:   RONGUERS
Proprietary Device Name:   RONGUERS
Registered Establishment Name:  SURGIMEN INSTRUMENTS.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   FEMORAL HEADS
Proprietary Device Name:   ZYRANOX ZIRCONIA FEMORAL HEADS, VITOX ALUMINA FEMORAL HEADS
Registered Establishment Name:  MORGAN ADVANCED CERAMICS.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   SPINE FIXATION SYSTEM
Proprietary Device Name:   K2M SPINE SYSTEM
Registered Establishment Name:  K2M, LLC.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR CERVICAL PLATE
Proprietary Device Name:   PYRENEES CERVICAL PLATE SYSTEM
Registered Establishment Name:  K2M, LLC.
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   VERTEBRAL BODY REPLACEMENT DEVICE
Proprietary Device Name:   ALEUTIAN SPACER SYSTEM
Registered Establishment Name:  K2M, LLC.
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   BANDAGE SKIN TRACTION KIT
Proprietary Device Name:   NON-INVASIVE TRACTION COMPONENT
Registered Establishment Name:  DR. SABHARWAL'S MEDICALS PVT, LTD..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF NEEDLE HOLDERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUMSIZ INDUSTRIES.

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