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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:   FORK
Generic Device Name:   VARIOUS MODELS
Proprietary Device Name:   FORK
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   IMPACTOR
Generic Device Name:   VARIOUS MODELS
Proprietary Device Name:   IMPACTOR
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   VARIOUS MODELS
Proprietary Device Name:   BURR
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   CORKSCREW
Generic Device Name:   VARIOUS MODELS
Proprietary Device Name:   CORKSCREW
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS MODELS
Proprietary Device Name:   WIRE CUTTER
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   BRACE, DRILL
Generic Device Name:   VARIOUS MODELS
Proprietary Device Name:   DRILL BRACE
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   VARIOUS MODELS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   ARTHROSCOPE AND ACCESSORIES
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   GUIDE, DRILL, LIGAMENT
Generic Device Name:   DRILL GUIDE
Proprietary Device Name:   DRILL GUIDE
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   RONGEUR
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   STARTER, BONE SCREW
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   PROBE
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MIASPAS TL
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   KNEE SYSTEMS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Generic Device Name:   CAST CUTTER
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Generic Device Name:   KNEE JOINT
Proprietary Device Name:   COLUMBUS KNEE
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   APPLIER, CERCLAGE
Generic Device Name:   CERCLAGE APPLIER
Proprietary Device Name:   CERCLAGE INSTRUMENT
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   PROSTHETIC HIP SYSTEM
Proprietary Device Name:   EXCIA HIP SYSTEM
Registered Establishment Name:  AESCULAP AG & CO. KG..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC NEEDLE HOLDER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AESCULAP SURGICAL INDUSTRIES SDN BHD.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  HARTMUT OERTEL CHIR. INSTRUMENTE GMBH.
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HARTMUT OERTEL CHIR. INSTRUMENTE GMBH.
Classification:   FILE
Generic Device Name:   VARIOUS TYPES OF FILES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HARTMUT OERTEL CHIR. INSTRUMENTE GMBH.
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES OF GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HARTMUT OERTEL CHIR. INSTRUMENTE GMBH.
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF PASSERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HARTMUT OERTEL CHIR. INSTRUMENTE GMBH.
Classification:   TAMP
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HARTMUT OERTEL CHIR. INSTRUMENTE GMBH.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HARTMUT OERTEL CHIR. INSTRUMENTE GMBH.
Classification:   IMPACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HARTMUT OERTEL CHIR. INSTRUMENTE GMBH.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  HARTMUT OERTEL CHIR. INSTRUMENTE GMBH.
Classification:   CALIPER
Generic Device Name:   CALIPER,CLINICAL USE
Proprietary Device Name:   CALIPER,CLINICAL USE
Registered Establishment Name:  OERTEL MEDIZINTECHNIK.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   STRIPPER
Proprietary Device Name:   STRIPPER
Registered Establishment Name:  OERTEL MEDIZINTECHNIK.
Classification:   PASSER
Generic Device Name:   PASSER
Proprietary Device Name:   TENDON PASSER
Registered Establishment Name:  OERTEL MEDIZINTECHNIK.

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Last Modified: 29 April 2006
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