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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:   BIT, DRILL
Generic Device Name:   BIT, DRILL
Proprietary Device Name:   WRISTJACK PRE-DRILL KIT
Registered Establishment Name:  HAND BIOMECHANICS LAB, INC..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   PIN, FIXATION, THREADED
Proprietary Device Name:   PIN, FIXATION, THREADED
Registered Establishment Name:  HAND BIOMECHANICS LAB, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   EXTERNAL WRIST FIXATOR
Proprietary Device Name:   WRISTJACK ORIF SYSTEM
Registered Establishment Name:  HAND BIOMECHANICS LAB, INC..
Classification:   SPLINT, TRACTION
Generic Device Name:   TRACTION SPLINT
Proprietary Device Name:   BUCK'S TRACTION SPLINT
Registered Establishment Name:  ORTHOPEDIC SYSTEMS, INC..
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   STANDARD HEAD HALTERS INCL. DISPOSIBLES
Registered Establishment Name:  ORTHOPEDIC SYSTEMS, INC..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   DISPOSABLE PELVIC TRACTION BELT
Registered Establishment Name:  ORTHOPEDIC SYSTEMS, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   PELVIC TRACTION APPARATUS
Proprietary Device Name:   PELVIC SURGERY KIT
Registered Establishment Name:  ORTHOPEDIC SYSTEMS, INC..
Classification:   SPLINT, TRACTION
Generic Device Name:   VARIOUS MODELS/SIZES EMERGENCY TRACTION SPLINTS
Proprietary Device Name:   MULTILPLE
Registered Establishment Name:  MINTO RESEARCH & DEVELOPMENT, INC..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   SNAP PIN
Proprietary Device Name:   SNAP FIXATION PIN
Registered Establishment Name:  SGARLATO LABORATORIES, INC..
Classification:   PROSTHESIS, TOE, CONSTRAINED, POLYMER
Generic Device Name:   TOE IMPLANTS, SILCONE
Proprietary Device Name:   GAIT IMPLANT, SHIP IMPLANT
Registered Establishment Name:  SGARLATO LABORATORIES, INC..
Classification:   PROSTHESIS, LIGAMENT, PTFE
Generic Device Name:   ENDOGRADE
Proprietary Device Name:   ENDOGRADE
Registered Establishment Name:  H.S. INTL. CO., INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   TRACTION SPLINT
Proprietary Device Name:   PIVOTTRAC
Registered Establishment Name:  REEL RESEARCH AND DEVELOPMENT, INC..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   GONIOMETER
Proprietary Device Name:   LEIGHTON FLEXOMETER
Registered Establishment Name:  LEIGHTON FLEXOMETER.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   KRONNER FOOT CASTING STAND
Proprietary Device Name:   KRONNER FOOT CASTING STAND
Registered Establishment Name:  KRONNER PROTOTYPES, INC..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   PELVIC TRACTION BELT
Proprietary Device Name:   PELVIC BELT
Registered Establishment Name:  SHAMROCK MEDICAL, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   PELVIC/CERVICAL TRACTION
Proprietary Device Name:   LUMBO-90; C-FLEX; ECONO-SERV
Registered Establishment Name:  SHAMROCK MEDICAL, INC..
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   CERVICAL TRACTION HALTER
Proprietary Device Name:   HEAD HALTER
Registered Establishment Name:  SHAMROCK MEDICAL, INC..
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   PELVIC SLING, CIRCUMFERENTIAL SACROILIAC SLING ORTHOSIS
Proprietary Device Name:   SAM SLING
Registered Establishment Name:  THE SEABERG COMPANY, INC..
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   NON-INVASIVE LUMBAR TRACTION COMPONENT
Proprietary Device Name:   GRAVITRAK
Registered Establishment Name:  SISKIYOU PACIFIC, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RICHARD WOLF GMBH.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RICHARD WOLF GMBH.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   PNEUMATIC POWERED ORTHPEDIC INSTRUMENT
Proprietary Device Name:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Registered Establishment Name:  RICHARD WOLF GMBH.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   ARTHROSCOPE
Registered Establishment Name:  RICHARD WOLF GMBH.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM
Proprietary Device Name:   INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM
Registered Establishment Name:  RICHARD WOLF GMBH.
Classification:   IMPACTOR
Generic Device Name:   IMPACTOR
Proprietary Device Name:   IMPACTOR
Registered Establishment Name:  RICHARD WOLF GMBH.
Classification:   EXTRACTOR
Generic Device Name:   EXTRACTOR
Proprietary Device Name:   EXTRACTOR
Registered Establishment Name:  RICHARD WOLF GMBH.
Classification:   PUSHER, SOCKET
Generic Device Name:   PUSHER
Proprietary Device Name:   PUSHER
Registered Establishment Name:  RICHARD WOLF GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   ORTHOPEDIC SURGICAL INSTRUMENT
Registered Establishment Name:  RICHARD WOLF GMBH.
Classification:   GUIDE, DRILL, LIGAMENT
Generic Device Name:   DRILL GUIDE
Proprietary Device Name:   ACL INSTRUMENT
Registered Establishment Name:  RICHARD WOLF GMBH.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   RONGEUR (MULTIPLE BRANDS)
Registered Establishment Name:  RICHARD WOLF GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RICHARD WOLF MEDICAL INSTRUMENTS CORP..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RICHARD WOLF MEDICAL INSTRUMENTS CORP..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   PNEUMATIC POWERED ORTHPEDIC INSTRUMENT
Proprietary Device Name:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Registered Establishment Name:  RICHARD WOLF MEDICAL INSTRUMENTS CORP..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   ARTHROSCOPE
Registered Establishment Name:  RICHARD WOLF MEDICAL INSTRUMENTS CORP..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM
Proprietary Device Name:   INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM
Registered Establishment Name:  RICHARD WOLF MEDICAL INSTRUMENTS CORP..
Classification:   IMPACTOR
Generic Device Name:   IMPACTOR
Proprietary Device Name:   IMPACTOR
Registered Establishment Name:  RICHARD WOLF MEDICAL INSTRUMENTS CORP..
Classification:   EXTRACTOR
Generic Device Name:   EXTRACTOR
Proprietary Device Name:   EXTRACTOR
Registered Establishment Name:  RICHARD WOLF MEDICAL INSTRUMENTS CORP..
Classification:   PUSHER, SOCKET
Generic Device Name:   PUSHER
Proprietary Device Name:   PUSHER
Registered Establishment Name:  RICHARD WOLF MEDICAL INSTRUMENTS CORP..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   ORTHOPEDIC SURGICAL INSTRUMENT
Registered Establishment Name:  RICHARD WOLF MEDICAL INSTRUMENTS CORP..
Classification:   GUIDE, DRILL, LIGAMENT
Generic Device Name:   DRILL GUIDE
Proprietary Device Name:   ACL INSTRUMENT
Registered Establishment Name:  RICHARD WOLF MEDICAL INSTRUMENTS CORP..

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Last Modified: 29 April 2006
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