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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:   DYNAMOMETER, NONPOWERED
Generic Device Name:   MANUAL MUSCLE TESTER; STATIC LIFT STATION
Proprietary Device Name:   MICROFET; FET 5000
Registered Establishment Name:  HOGGAN HEALTH INDUSTRIES, INC..
Classification:   PROSTHESIS, FINGER, POLYMER
Generic Device Name:   FINGER PROSTHESIS [GLUE-ON NOT IMPLANTS]
Registered Establishment Name:  ROCKY MOUNTAIN ANAPLASTOLOGY, INC..
Classification:   CEMENT OBTURATOR
Generic Device Name:   ORTHOPLUG
Proprietary Device Name:   CEMENT RESTRICTOR BONE PLUG
Registered Establishment Name:  SUNMEDICA.
Classification:   EVACUATOR, VAPOR, CEMENT MONOMER
Generic Device Name:   CEMENT MONOMER EVACUATOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER PUERTO RICO, LTD..
Classification:   CEMENT, BONE, VERTEBROPLASTY
Generic Device Name:   PMMA BONE CEMENT
Proprietary Device Name:   SPINEPLEX RADIOPAQUE BONE CEMENT
Registered Establishment Name:  STRYKER PUERTO RICO, LTD..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF STERILE, DISPOSABLE BRUSHES AND CEMENT SCULPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER PUERTO RICO, LTD..
Classification:   MONITOR, PRESSURE, INTRACOMPARTMENTAL
Generic Device Name:   PRESSURE MONITOR AND VARIOUS TYPES OF STERILE AND NON-STERILE ACCESSORIES
Proprietary Device Name:   STRYKER PRESSURE MONITOR SYSTEM
Registered Establishment Name:  STRYKER PUERTO RICO, LTD..
Classification:   CEMENT OBTURATOR
Generic Device Name:   OBTURATOR
Proprietary Device Name:   BIOPREP CEMENT OBTURATOR
Registered Establishment Name:  STRYKER PUERTO RICO, LTD..
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   CEMENT MIXERS FOR CLINICAL USE
Proprietary Device Name:   MIXEVAC CEMENT MIXER AND FUME EVACUATOR, MIXEVAC II HIGH VACUUM KIT,MIXEVAC II H
Registered Establishment Name:  STRYKER PUERTO RICO, LTD..
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS ARTHROSCOPIC INSTRUMENTS
Proprietary Device Name:   MULTIPLE ARTHROSCOPIC INSTRUMENTS
Registered Establishment Name:  STRYKER PUERTO RICO, LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Registered Establishment Name:  STRYKER ENDOSCOPY.
Classification:   KNIFE, ORTHOPEDIC
Registered Establishment Name:  STRYKER ENDOSCOPY.
Classification:   PROSTHESIS, LIGAMENT
Registered Establishment Name:  STRYKER ENDOSCOPY.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Registered Establishment Name:  STRYKER ENDOSCOPY.
Classification:   COMPONENT, TRACTION, INVASIVE
Registered Establishment Name:  STRYKER ENDOSCOPY.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE AND ACCESSORIES
Proprietary Device Name:   VARIOUS STRYKER ARTHROSCOPES AND ACCESSORIES
Registered Establishment Name:  STRYKER ENDOSCOPY.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   HERMES TPS
Proprietary Device Name:   STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
Registered Establishment Name:  STRYKER ENDOSCOPY.
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   VARIOUS ANCHOR SYSTEMS
Proprietary Device Name:   BIOABSORBABLE SUTURE ANCHORS
Registered Establishment Name:  STRYKER ENDOSCOPY.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   INTERFERENCE SCREW
Proprietary Device Name:   STRYKER INTERFERENCE AND WEDGE SCREW SYSTEMS
Registered Establishment Name:  STRYKER ENDOSCOPY.
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   SCREW
Proprietary Device Name:   STRYKER TITANIUM CROSS SCREW AND CROSS-PINNED INTERFERENCE SCREW SYSTEMS
Registered Establishment Name:  STRYKER ENDOSCOPY.
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   WEDGE SUTURE ANCHOR
Proprietary Device Name:   STRYKER WEDGE SUTURE ANCHOR SYSTEM
Registered Establishment Name:  STRYKER ENDOSCOPY.
Classification:   PASSER
Generic Device Name:   PASSERS
Proprietary Device Name:   STRYKER SUTURE SLIDERS
Registered Establishment Name:  STRYKER ENDOSCOPY.
Classification:   BONE CEMENT
Generic Device Name:   BONE CEMENT
Proprietary Device Name:   SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT
Registered Establishment Name:  STRYKER INSTRUMENTS.
Classification:   DISPENSER, CEMENT
Generic Device Name:   CEMENT DISPENSER AND VARIOUS STERILE ACCESSORIES
Proprietary Device Name:   DUALSPEED CEMENT INJECTION GUN
Registered Establishment Name:  STRYKER INSTRUMENTS.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   MANUAL CAST APPLICATION/REMOVAL INSTRUMENT
Proprietary Device Name:   VARIOUS SIZES OF CAST SPREADERS AND A PLASTER DISPENSER
Registered Establishment Name:  STRYKER INSTRUMENTS.
Classification:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Generic Device Name:   VARIOUS ELECTRIC CAST VACUUMS AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER INSTRUMENTS.
Classification:   EVACUATOR, VAPOR, CEMENT MONOMER
Generic Device Name:   CEMENT MONOMER EVACUATOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER INSTRUMENTS.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER INSTRUMENTS.
Classification:   COMPONENT, CAST
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER INSTRUMENTS.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   75K DRILL WITH VARIOUS TYPES OF ATTACHMENTS
Proprietary Device Name:   STRYKER TOTAL PERFORMANCE SYSTEM 75K STRAIGHT DRILL WITH VARIOUS TYPES OF STRAIG
Registered Establishment Name:  STRYKER INSTRUMENTS.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   HERMES TPS
Proprietary Device Name:   STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
Registered Establishment Name:  STRYKER INSTRUMENTS.
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   CEMENT MIXERS FOR CLINICAL USE
Proprietary Device Name:   MIXEVAC CEMENT MIXER AND FUME EVACUATOR, MIXEVAC II HIGH VACUUM KIT,MIXEVAC II H
Registered Establishment Name:  STRYKER INSTRUMENTS.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF STERILE, DISPOSABLE BRUSHES AND CEMENT SCULPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER INSTRUMENTS.
Classification:   MONITOR, PRESSURE, INTRACOMPARTMENTAL
Generic Device Name:   PRESSURE MONITOR AND VARIOUS TYPES OF STERILE AND NON-STERILE ACCESSORIES
Proprietary Device Name:   STRYKER PRESSURE MONITOR SYSTEM
Registered Establishment Name:  STRYKER INSTRUMENTS.
Classification:   PROBE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER INSTRUMENTS.
Classification:   CEMENT OBTURATOR
Generic Device Name:   OBTURATOR
Proprietary Device Name:   BIOPREP CEMENT OBTURATOR
Registered Establishment Name:  STRYKER INSTRUMENTS.
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   PELVIC BELT
Registered Establishment Name:  FREEMAN MFG. CO..
Classification:   SPLINT, TRACTION
Generic Device Name:   TRACTION LEGGING
Registered Establishment Name:  FREEMAN MFG. CO..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS MODELS OF COMPLETE TRACTION UNITS.
Proprietary Device Name:   COMPLETE TRACTION UNIT
Registered Establishment Name:  FREEMAN MFG. CO..
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   VARIOUS MODELS OF HEAD HALTERS
Registered Establishment Name:  FREEMAN MFG. CO..

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Last Modified: 29 April 2006
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