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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:   BONE MILL
Generic Device Name:   TYPES OF BONE MILLS
Proprietary Device Name:   MILTEX BRAND BONE MILLS
Registered Establishment Name:  MILTEX, INC..
Classification:   COMPONENT, CAST
Generic Device Name:   CAST COMPONENT
Proprietary Device Name:   SILVERSEAL
Registered Establishment Name:  NOBLE FIBER TECHNOLOGIES, INC..
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   NON-POWERED DYNAMOMETER
Proprietary Device Name:   GRIP STRENGTH DEVICE
Registered Establishment Name:  PRINCETON PARTNERS/DEVCOM.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   NON-POWERED GONIOMETER
Proprietary Device Name:   GONIOMETER
Registered Establishment Name:  PRINCETON PARTNERS/DEVCOM.
Classification:   CALIPER
Generic Device Name:   CALIPER
Proprietary Device Name:   SPINAL EXCURSION METER
Registered Establishment Name:  PRINCETON PARTNERS/DEVCOM.
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   DYNAMOMETER & HAND DYNAMOMETER
Proprietary Device Name:   TEKDYNE INCENTIVE DYNAMOMETER & HAND DYNAMOMETER
Registered Establishment Name:  TEKDYNE CORP..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   PELVIC BELT
Proprietary Device Name:   PELVIC BELT
Registered Establishment Name:  FREDERICK LEE, INC..
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   VARIOUS
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  AESCULAP, INC..
Classification:   STAPLE DRIVER
Generic Device Name:   VARIOUS
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  AESCULAP, INC..
Classification:   CERCLAGE, FIXATION
Generic Device Name:   VARIOUS
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  AESCULAP, INC..
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   VARIOUS
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  AESCULAP, INC..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   VARIOUS
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  AESCULAP, INC..
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, INC..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AESCULAP, INC..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP, INC..
Classification:   PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP, INC..
Classification:   SPLINT, TRACTION
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP, INC..
Classification:   PROTRACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP, INC..
Classification:   BROACH
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP, INC..
Classification:   RONGEUR
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP, INC..
Classification:   PROSTHESIS, KNEE, HINGED (METAL-METAL)
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP, INC..
Classification:   PROSTHESIS, KNEE, HEMI-, FEMORAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP, INC..
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP, INC..
Classification:   STARTER, BONE SCREW
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP, INC..
Classification:   PROBE
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP, INC..
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP, INC..
Classification:   CALIPER
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP, INC..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  AESCULAP, INC..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SPINAL SYSTEM
Proprietary Device Name:   PEDICLE SCREW SPINAL SYSTEM
Registered Establishment Name:  AESCULAP, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   INSTRUMENT,SURGICAL,ORTHOPEDIC,PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Proprietary Device Name:   INSTRUMENT,SURGICAL,ORTHOPEDIC,PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Registered Establishment Name:  AESCULAP, INC..
Classification:   IMPACTOR
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  AESCULAP, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   INSTRUMENT,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Proprietary Device Name:   INSTRUMENT,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Registered Establishment Name:  AESCULAP, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   PELVIC BONE CLAMP
Proprietary Device Name:   PELVIC BONE CLAMP
Registered Establishment Name:  AESCULAP, INC..
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   ARTHROSCOPIC ACCESSORIES
Proprietary Device Name:   ARTHROSCOPIC ACCESSORIES
Registered Establishment Name:  AESCULAP, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Generic Device Name:   PROSTHETIC HIP SYSTEM
Proprietary Device Name:   EXCIA HIP SYSTEM
Registered Establishment Name:  AESCULAP, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   PROSTHETIC HIP SYSTEM
Proprietary Device Name:   EXCIA HIP SYSTEM
Registered Establishment Name:  AESCULAP, INC..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   CALCIUM BONE VOID FILLER
Proprietary Device Name:   PROSPACE DBM
Registered Establishment Name:  AESCULAP, INC..
Classification:   WRENCH
Generic Device Name:   WRENCH
Proprietary Device Name:   WRENCH
Registered Establishment Name:  HAND BIOMECHANICS LAB, INC..
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   EXTERNAL FIXATOR SYSTEM
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HAND BIOMECHANICS LAB, INC..

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Last Modified: 29 April 2006
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