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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:   GAUGE, DEPTH
Generic Device Name:   PINCH GAUGE
Proprietary Device Name:   JAMAR HYDRAULIC PINCH GAUGE (5030 HPG)
Registered Establishment Name:  SAEHAN CORPORATION.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   GONIOMETER - FINGER
Proprietary Device Name:   GONIOMETER - FINGER
Registered Establishment Name:  SAEHAN CORPORATION.
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   HAND DYNAMOMETER
Proprietary Device Name:   VARIOUS TYPES OF HYDRAULIC HAND DYNAMOMETERS
Registered Establishment Name:  SAEHAN CORPORATION.
Classification:   DYNAMOMETER, AC-POWERED
Generic Device Name:   DIGITAL HAND DYNAMOMETER & DIGITAL PINCH GAUGE
Proprietary Device Name:   SH5003 & SH5006
Registered Establishment Name:  SAEHAN CORPORATION.
Classification:   CALIPER
Generic Device Name:   CALIPER ORTHOPEDIC
Proprietary Device Name:   CALIPER ORTHOPEDIC
Registered Establishment Name:  SALEEM SURGIO (REGD).
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS ORTHOPEDIC
Proprietary Device Name:   SCISSORS ORTHOPEDIC
Registered Establishment Name:  SALEEM SURGIO (REGD).
Classification:   EXTRACTOR
Generic Device Name:   EXTRACTOR ORTHOPEDIC
Proprietary Device Name:   EXTRACTOR ORTHOPEDIC
Registered Establishment Name:  SALEEM SURGIO (REGD).
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES OF PROBES
Proprietary Device Name:   PROBE (MULTIPLE BRANDS)
Registered Establishment Name:  GLORIOUS MERCANTILE CORP. (PVT) LTD..
Classification:   RONGEUR
Generic Device Name:   RONG. ORTHO, STILL LUER
Proprietary Device Name:   RONGEUR, ORTHOPEDIC
Registered Establishment Name:  ACCURAY SURGICALS, LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   HIMALAYA CATALOGUE NO. H26-2800 TO H32-3380
Proprietary Device Name:   HIMALAYA CATALOGUE NO. H26-2800 TO H32-3380
Registered Establishment Name:  HIMALAYA TRADING COMPANY (PVT) LTD..
Classification:   PUSHER, SOCKET
Generic Device Name:   VARIOUS MODELS OF SOCKET PUSHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   RONGEUR
Generic Device Name:   VARIOUS MODELS OF RONGEUR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS MODELS SURGICAL STRIPPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   TREPHINE
Generic Device Name:   VARIOUS MODELS OF TREPHINES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS MODELS OF WIRE TWISTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   WRENCH
Generic Device Name:   VARIOUS MODELS OF WRENCHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   SKID, BONE
Generic Device Name:   VARIOUS MODELS OF BONE SKIDS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS MODELS OF WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   VARIOUS MODELS OF PROSTHESIS DRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   VARIOUS MODELS OF NONPOWERED DYNAMOMETERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS MODELS EXTRACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   FILE
Generic Device Name:   VARIOUS MODELS OF FILES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS MODELS OF GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   BURR, ORTHOPEDIC
Proprietary Device Name:   BURR, ORTHOPEDIC
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   BIT, DRILL
Generic Device Name:   DRILL SURGICAL ORTHOPEDIC
Proprietary Device Name:   DRILL SURGICAL ORTHOPEDIC
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER ORTHOPEDIC
Proprietary Device Name:   SCREWDRIVER ORTHOPEDIC
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   SCISSORS ORTHOPEDIC
Proprietary Device Name:   SCISSORS ORTHOPEDIC
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   IMPACTOR
Generic Device Name:   VARIOUS MODELS OF IMPACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   PROBE
Generic Device Name:   VARIUOS MODELS OF PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS MODELS ORTHOPEDIC KNIFE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   PROTRACTOR
Generic Device Name:   VARIOUS MODELS OF PROTRACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   PUNCH, FEMORAL NECK
Generic Device Name:   VARIOUS MODELS OF FEMORAL NECK PUNCH
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   APPLIER, CERCLAGE
Generic Device Name:   VARIOUS MODELS OF CERCLAGE APPLIERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   AWL
Generic Device Name:   VARIOUS MODELS OF AWLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   BRACE, DRILL
Generic Device Name:   VARIOUS MODELS OF DRILL BRACES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   VARIOUS MODELS OF GONIOMETERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   CALIPER
Generic Device Name:   VARIOUS MODELS OF CALIPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS ORTHOPEDIC
Proprietary Device Name:   SCISSORS ORTHOPEDIC
Registered Establishment Name:  DYNAMIC SURGICAL (PVT) LTD.
Classification:   PROTRACTOR
Generic Device Name:   PROTRACTOR ORTHOPEDIC
Proprietary Device Name:   PROTRACTOR ORTHOPEDIC
Registered Establishment Name:  DYNAMIC SURGICAL (PVT) LTD.

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Last Modified: 29 April 2006
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