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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:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GROWDENT SURGICAL CO (PVT) LTD.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   B. ALI IMPEX
Registered Establishment Name:  B. ALI IMPEX.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   P.H.D. SURGICAL MANUFACTURE
Registered Establishment Name:  P.H.D. SURGICAL MANUFACTURE.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   BAJWA SURGICAL WORKS
Registered Establishment Name:  BAJWA SURGICAL WORKS.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   COMMIC SURGICO
Registered Establishment Name:  COMMIC SURGICO.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   COMMIC SURGICO
Registered Establishment Name:  COMMIC SURGICO.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   COMMIC SURGICO
Registered Establishment Name:  COMMIC SURGICO.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   COMMIC SURGICO
Registered Establishment Name:  COMMIC SURGICO.
Classification:   EXTRACTOR
Generic Device Name:   EXTRACTOR
Proprietary Device Name:   COMEDONE, UNA, VARIOUS
Registered Establishment Name:  PROTEC SURGICAL.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ARTICULATING RETRACTOR
Proprietary Device Name:   DEMMI RETRACTOR
Registered Establishment Name:  KELMAR MEDICAL, LLC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   CARE & CURE SURGICO
Registered Establishment Name:  CARE & CURE SURGICO.
Classification:   PROBE
Generic Device Name:   PROBES
Proprietary Device Name:   CARE & CURE SURGICO
Registered Establishment Name:  CARE & CURE SURGICO.
Classification:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Generic Device Name:   PORTABLE CAST CUTTER,SWISSEX
Proprietary Device Name:   SWISSEX
Registered Establishment Name:  SIGEMA MEDICAL GMBH.
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   SHAVER BLADES, ARTHROSCOPIC SHAVER BLADE
Proprietary Device Name:   CTC SHAVERS
Registered Establishment Name:  SIGEMA MEDICAL GMBH.
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES OF PROBES
Proprietary Device Name:   ARTHROPIC
Registered Establishment Name:  ALLEZ MEDICAL APPLICATIONS, INC..
Classification:   PROSTHESIS, HIP, FEMORAL, RESURFACING
Generic Device Name:   FEMORAL HEAD RESURFACING PROSTHESIS
Proprietary Device Name:   HEMICAP(TM) FEMORAL HEAD RESURFACING PROSTHESIS
Registered Establishment Name:  ARTHROSURFACE, INC..
Classification:   PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Generic Device Name:   SHOULDER JOINT HUMERAL (HEMI-SHOULDER) METALLIC RESURFACING PROSTHESIS
Proprietary Device Name:   HEMICAP (TM) HUMERAL HEAD RESURFACING PROSTHESIS
Registered Establishment Name:  ARTHROSURFACE, INC..
Classification:   PROSTHESIS, TOE, HEMI-, PHALANGEAL
Generic Device Name:   GREAT TOE RESURFACING PROSTHESIS
Proprietary Device Name:   HEMICAP TOE JOINT RESURFACING PROSTHESIS
Registered Establishment Name:  ARTHROSURFACE, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC RESURFACING INSTRUMENT
Proprietary Device Name:   HEMICAP RESURFACING INSTRUMENT KIT
Registered Establishment Name:  ARTHROSURFACE, INC..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   VARIOUS TYPES OF PELVIC TRACTION BELTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCOTT SPECIALTIES, INC..
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   VARIOUS TYPES OF HEAD HALTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCOTT SPECIALTIES, INC..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   VARIOUS TYPES OF PELVIC TRACTION BELTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCOTT SPECIALTIES, INC..
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   VARIOUS TYPES OF HEAD HALTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCOTT SPECIALTIES, INC..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW
Proprietary Device Name:   PEDICLE SCREW
Registered Establishment Name:  JOHANSON MANUFACTURING CORPORATION.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW
Proprietary Device Name:   PEDICLE SCREW
Registered Establishment Name:  JOHANSON DOMINICANA S.A..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS
Proprietary Device Name:   VARIOUS TYPES OF SCISSORS
Registered Establishment Name:  MEDICAL MARKETING SPECIALIST INC.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   VARIOUS TYPES OF RONGEURS
Registered Establishment Name:  MEDICAL MARKETING SPECIALIST INC.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF WIRE CUTTERS
Proprietary Device Name:   VARIOUS TYPES OF WIRE CUTTERS
Registered Establishment Name:  MEDICAL MARKETING SPECIALIST INC.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   NOBBY MEDICAL INSTRUMENTS (PVT) LTD
Registered Establishment Name:  NOBBY MEDICAL INSTRUMETNS (PVT) LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SUNNY IMPEX
Registered Establishment Name:  SUNNY IMPEX.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   KIRSCHNER WIRE
Proprietary Device Name:   K-WIRE
Registered Establishment Name:  ALPHA LASER S.A..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   BONE FIXATION STAPLE
Proprietary Device Name:   SOLUSTAPLE
Registered Establishment Name:  ALPHA LASER S.A..
Classification:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Generic Device Name:   CAST REMOVAL INSTRUMENTS
Proprietary Device Name:   CAST REMOVAL INSTRUMENTS
Registered Establishment Name:  SHEFFMED TRADE SERVICES LIMITED.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   NONPOWERED ORTHOPEDIC TRACTION APPARATUS AND ACCESSORIES
Proprietary Device Name:   GEMORE TRACTION, GEM-TRACTION, ULTRA-TRACTION
Registered Establishment Name:  GEMORE TECHNOLOGY CO., LTD..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   CTRAC SPLINT
Proprietary Device Name:   MDCTRAC
Registered Establishment Name:  MEDEVICE CORPORATION.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   K-WIRE END PROTECTOR
Proprietary Device Name:   K-FIX
Registered Establishment Name:  ESTER.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   FLAT FOOT IMPLANT
Proprietary Device Name:   KALIX
Registered Establishment Name:  ESTER.
Classification:   PROSTHESIS, KNEE, HEMI-, TIBIAL, RESURFACING (UNCEMENTED)
Generic Device Name:   VARIOUS TYPES OF KNEE PROSTHESIS, HEMI-TIBIAL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CONFORMIS, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BIOABSORBABLE INTERFERENCE SCREW
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ADVANCED BIOMATERIALS.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   KIT OF VARIOUS STERILE & NON STERILE SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ADVANCED BIOMATERIALS.

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Last Modified: 29 April 2006
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