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US Food and Drug Administration (FDA) - Orthopedic Devices Registration |
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US Food and Drug Administration (FDA) - Orthopedic Devices Registration |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: LIGAMENT TENSIONING INSTRUMENT Proprietary Device Name: LIBRA Registered Establishment Name: SYNVASIVE TECHNOLOGY, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS, ORTHOPEDIC, SURGICAL (VARIOUS TYPES) Proprietary Device Name: SCISSORS, ORTHOPEDIC, SURGICAL (MULTIPLE BRANDS) Registered Establishment Name: AEMCO Z.E. (PVT), LTD.. |
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Classification: PROBE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: AEMCO Z.E. (PVT), LTD.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: BANDAGE SCISSORS Registered Establishment Name: MEDCO SUPPLY COMPANY, INC.. |
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Classification: INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT Generic Device Name: SONIC, ORTHOPEDIC SURGICAL INSTRUMENT SYSTEM Proprietary Device Name: ULTRA-DRIVE SURGICAL SYSTEM Registered Establishment Name: ARTHROTEK, INC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: MICRO POWER SUGICAL SYSTEM Proprietary Device Name: MICRO POWER SUGICAL SYSTEM Registered Establishment Name: ARTHROTEK, INC.. |
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Classification: EVACUATOR, VAPOR, CEMENT MONOMER Generic Device Name: SMOKE EVACUATOR Proprietary Device Name: SURG/ASSIST MODEL S/A-1 Registered Establishment Name: ANDY FRISQUE LASER SYSTEMS. |
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Classification: BIT, DRILL Generic Device Name: CRANIAL DRILL BIT Proprietary Device Name: CODMAN Registered Establishment Name: GREYSTONE OF LINCOLN, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: TROKAMED GMBH. |
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Classification: INSTRUMENT, CAST REMOVAL, AC-POWERED Generic Device Name: CC4, CC5, CC6 AND CCB WITH OR WITHOUT EXTRACTION Proprietary Device Name: CLEANCAST SAW SYSTEM Registered Establishment Name: DE SOUTTER MEDICAL LTD.. |
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Classification: COMPONENT, CAST Generic Device Name: CAST SAW Proprietary Device Name: CLEAN CAST SAW SYSTEM Registered Establishment Name: DE SOUTTER MEDICAL LTD.. |
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Classification: RONGEUR Generic Device Name: VARIOUS TYPES OF PLIERS, ORTHOPEDIC Proprietary Device Name: RONGEUR Registered Establishment Name: KASHMIR SURGICAL CO.. |
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Classification: CUTTER, WIRE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: KASHMIR SURGICAL CO.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: ARM TRACTION DEVICE Proprietary Device Name: ARM TRAC Registered Establishment Name: BREG, INC., AN ORTHOFIX COMPANY. |
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Classification: EXTRACTOR Generic Device Name: APPENDICE EXTRACTOR AND REDUCTOR FOR ENDOSCOPIC SURGERY Proprietary Device Name: EXTRACTOR Registered Establishment Name: EDLO S.A. PRODUTOS MEDICOS. |
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Classification: SPLINT, TRACTION Generic Device Name: SPLINT TRACTION Proprietary Device Name: ADAMS SPLINT TRACTION Registered Establishment Name: E.M. ADAMS CO., INC.. |
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Classification: HALTER, HEAD, TRACTION Generic Device Name: HEAD HALTER Proprietary Device Name: ADAMS HEAD HALTER Registered Establishment Name: E.M. ADAMS CO., INC.. |
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Classification: BELT, PELVIC, TRACTION Generic Device Name: PELVIC TRACTION BELT Proprietary Device Name: ADAMS PELVIC TRACTION BELT Registered Establishment Name: E.M. ADAMS CO., INC.. |
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Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: RONGEUR Registered Establishment Name: TRAUTEC-EQUIPAMENTOS CIRURGICOS LTDA.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF MANUAL SURGICAL INSTRUMENTS Proprietary Device Name: NEMCOMED ORTHOPEDIC SURGICAL INSTRUMENTS Registered Establishment Name: NEMCOMED, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: VARIOUS TYPES OF IRRIGATION SETS Proprietary Device Name: MULTIPLE Registered Establishment Name: VITAL CONCEPTS, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: B. WEBBER & CO. Registered Establishment Name: B. WEBBER & CO.. |
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Classification: PROBE Generic Device Name: PROBES Proprietary Device Name: B. WEBBER & CO. Registered Establishment Name: B. WEBBER & CO.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: RIGID FIXATION SYSTEM Proprietary Device Name: MASTERPIECES Registered Establishment Name: BAUSCH & LOMB, INC.. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: OSTEOTOMES Proprietary Device Name: ION BOND OSTEOTOMES Registered Establishment Name: BAUSCH & LOMB, INC.. |
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Classification: CUTTER, WIRE Generic Device Name: WIRE CUTTER Proprietary Device Name: GUILFORD WRIGHT WIRE CUTTER Registered Establishment Name: BAUSCH & LOMB, INC.. |
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Classification: STRIPPER, SURGICAL Generic Device Name: FASCIA STRIPPER Proprietary Device Name: CRAWFORD FASCIA STRIPPER Registered Establishment Name: BAUSCH & LOMB, INC.. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: HOLDER, NEEDLE; ORTHOPEDIC Proprietary Device Name: HOLDER, NEEDLE; ORTHOPEDIC Registered Establishment Name: ELCON MEDICAL INSTRUMENTS GMBH. |
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Classification: KNIFE, ORTHOPEDIC Generic Device Name: MENISCOTOME Proprietary Device Name: SMILLIE MENISCUS CHISEL, SMILLIE MENISCOTOME Registered Establishment Name: ELCON MEDICAL INSTRUMENTS GMBH. |
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Classification: RONGEUR Generic Device Name: BONE RONGEURS Proprietary Device Name: BONE RONGEUR, VARIOUS MODELS, ORTHOPEDIC Registered Establishment Name: ELCON MEDICAL INSTRUMENTS GMBH. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS Proprietary Device Name: ORTHOPLAST Registered Establishment Name: MICROTEK DOMINICA, S.A.. |
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Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: RONGEUR Registered Establishment Name: K.K. METALLIC INDUSTRIES. |
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Classification: CUTTER, WIRE Generic Device Name: VARIOUS Proprietary Device Name: CUTTER, WIRE Registered Establishment Name: K.K. METALLIC INDUSTRIES. |
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Classification: SPLINT, TRACTION Generic Device Name: TRACTION TONG Proprietary Device Name: TYPE GWT GARDNER-WELLS TRACTION TONG Registered Establishment Name: INTEGRA RADIONICS, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BORE SCREWS Proprietary Device Name: DUVAL BONE SCREWS Registered Establishment Name: VILEX, INC.. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: EXTERNAL FIXATION Proprietary Device Name: X-FIX Registered Establishment Name: VILEX, INC.. |
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Classification: CERCLAGE, FIXATION Generic Device Name: SURGICAL CABLE SYSTEM Proprietary Device Name: LOW-PROFILE AND TOP HAT CABLE SYSTEMS Registered Establishment Name: WHITESIDE BIOMECHANICS, INC.. |
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Classification: RONGEUR Generic Device Name: VARIOUS SIZES AND SHAPES Proprietary Device Name: WHITESIDE BIOMECHANIC ALLIGATOR RONGEURS AND OSTEOGATOR Registered Establishment Name: WHITESIDE BIOMECHANICS, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BONE SCREW Proprietary Device Name: WHITESIDE BIOMECHANIC CANCELLOUS BONE SCREW Registered Establishment Name: WHITESIDE BIOMECHANICS, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED Generic Device Name: CERAMIC FEMORAL HEAD Proprietary Device Name: WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD Registered Establishment Name: WHITESIDE BIOMECHANICS, INC.. |
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