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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:   IMPACTOR
Generic Device Name:   VARIOUS STYLES OF IMPACTORS
Proprietary Device Name:   ORTHOPEDIC IMPACTOR
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   PROBE
Generic Device Name:   VARIOUS STYLES OF ORTHOPEDIC) PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF KNIVES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TYPES OF DRILL BITS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES OF PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   WRENCH
Generic Device Name:   VARIOUS TYPES OF WRENCHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   CERCLAGE, FIXATION
Generic Device Name:   VARIOUS TYPES OF CERCLAGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   IMPACTOR
Generic Device Name:   VARIOUS STYLES OF IMPACTORS
Proprietary Device Name:   ORTHOPEDIC IMPACTOR
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES AND SIZES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES AND SIZES OF ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   TAMP
Generic Device Name:   VARIOUS TYPES AND SIZES OF TAMPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS TYPES AND SIZES OF SCREWDRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   CALIPER
Generic Device Name:   VARIOUS TYPES AND SIZES OF CALIPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   CEMENT, BONE, VERTEBROPLASTY
Generic Device Name:   RADIOPAQUE BONE CEMENT
Proprietary Device Name:   AVA-TEX
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   COMPONENT, CAST
Generic Device Name:   UNDER CAST PADDING
Proprietary Device Name:   UNDER CAST PADDING
Registered Establishment Name:  MEDLINE INDUSTRIES, INC..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   PELVIC TRACTION BELT
Proprietary Device Name:   TETRA PELVIC TRACTION BELT
Registered Establishment Name:  TETRA MEDICAL SUPPLY CORP..
Classification:   SPLINT, TRACTION
Generic Device Name:   VARIOUS ANKLE SPLINT STYLES
Proprietary Device Name:   SPLINT, TRACTION
Registered Establishment Name:  TETRA MEDICAL SUPPLY CORP..
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   DYNAMOMETER, PINCH METER
Proprietary Device Name:   DYNAMOMETER, 20LB PINCH METER, 50LB DYNAMOMETER, PINCH METER
Registered Establishment Name:  PATTERSON MEDICAL PRODUCTS, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   ARM WEIGHT CUFFS, SAND BAGS
Proprietary Device Name:   ARM CUFF WEIGHT, SADDLEBAG WEIGHT KIT
Registered Establishment Name:  PATTERSON MEDICAL PRODUCTS, INC..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   DIGIT-O-METER GAUGE, FINGER CIRCUMFERENCE GAUGE, BEOK PLASTIC GONIOMETER 63/4,
Proprietary Device Name:   DIGIT-O-METER GAUGE, FINGER CIRCUMFERENCE GAUGE, BEOK PLASTI
Registered Establishment Name:  PATTERSON MEDICAL PRODUCTS, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS, ORTHOPEDIC, SURGICAL
Proprietary Device Name:   SCISSORS, ORTHOPEDIC, SURGICAL
Registered Establishment Name:  SURGIPATH MEDICAL INDUSTRIES, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   MEDCO
Registered Establishment Name:  MEDCO INSTRUMENTS, INC..
Classification:   RONGEUR
Generic Device Name:   USED IN ORTHOPEDIC SURGERY
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED INTERNATIONAL, INC..
Classification:   IMPACTOR
Generic Device Name:   USED IN ORTHOPEDIC SURGERY
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED INTERNATIONAL, INC..
Classification:   TAMP
Generic Device Name:   USED IN ORTHOPEDIC PROCEDURES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED INTERNATIONAL, INC..
Classification:   CUTTER, WIRE
Generic Device Name:   USED IN ORTHOPEDIC SURGERY
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED INTERNATIONAL, INC..
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED INTERNATIONAL, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   USED IN ORTHOPEDIC SURGERY
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED INTERNATIONAL, INC..
Classification:   AWL
Generic Device Name:   STERNUM PERFORATING AWL/CARDIO PROCEDURES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED INTERNATIONAL, INC..
Classification:   EXTRACTOR
Generic Device Name:   EXTRACTOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED INTERNATIONAL, INC..
Classification:   STRIPPER, SURGICAL
Generic Device Name:   USED IN HAND SURGERY
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INSTRUMED INTERNATIONAL, INC..
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SURGICAL INSTRUMENT SERVICE CO..
Classification:   CALIPER
Generic Device Name:   CALIPERS
Registered Establishment Name:  CLOVER GLOBAL GROUP, INC..
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   CEERVICAL TRACTION KIT
Proprietary Device Name:   CERVICAL TRACTION KIT
Registered Establishment Name:  BEIERSDORF, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   CERVICAL TRACTION KIT, OVER DOOR
Proprietary Device Name:   FUTURO CERVICAL TRACTION KIT, WHITE
Registered Establishment Name:  BEIERSDORF, INC..
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   TRACTION HEAD HALTER
Proprietary Device Name:   TRACTION HEAD HALTER
Registered Establishment Name:  SURGICAL APPLIANCE INDUSTRIES, INC..
Classification:   UNIT, TRACTION, HIP, NON-POWERED, NON-PENETRATING
Generic Device Name:   PELVIC TRACTION KIT
Proprietary Device Name:   PELVIC TRACTION KIT
Registered Establishment Name:  SURGICAL APPLIANCE INDUSTRIES, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   ANKLE TRACTION KIT
Proprietary Device Name:   ANKLE TRACTION KIT
Registered Establishment Name:  SURGICAL APPLIANCE INDUSTRIES, INC..
Classification:   UNIT, TRACTION, HIP, NON-POWERED, NON-PENETRATING
Generic Device Name:   PELVIC TRACTION KIT
Proprietary Device Name:   PELVIC TRACTION KIT
Registered Establishment Name:  P.C.P. CHAMPION.
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   TRACTION HEAD HALTER
Proprietary Device Name:   TRACTION HEAD HALTER
Registered Establishment Name:  P.C.P. CHAMPION.

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Last Modified: 29 April 2006
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