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HRX

681 FDA 510(k) clearances · Product code

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RecordFirmDate
FLEXLITE CAMERA (K122134)Spine View, Inc.2012-12-27
KYPHON EXPRESS II INFLATABLE BONE TAMPS (K123771)Medtronic2012-12-21
XTOOL (K122861)Ouroboros Medical2012-12-07
VERTIFLEX DIRECT DECOMPRESSION SYSTEM (K122662)Vertiflex, Inc.2012-11-13
INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY (K121482)Theken Spine, LLC2012-08-28
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) (K121548)Spine View, Inc.2012-08-16
ALTOMEC ARTHROSCOPE (K112548)Altomec Endoscopy, Inc.2012-08-15
ESPIN (K120553)Nlt Spine, Ltd.2012-08-09
ENSPIRE DISCECTOMY SYSTEM (K120680)Spine View, Inc.2012-06-26
TRANSCORP SPINAL ACCESS SYSTEM (K113352)Transcorp, Inc.2012-04-16
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) (K113362)Spine View, Inc.2012-02-10
MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS (K113028)Medisiss2011-12-20
ENSPIRE DEBRIDER SYSTEM (K110992)Spine View, Inc.2011-10-21
KYPHON INFLATION SYRINGE (K103231)Medtronic Spine, LLC2011-01-24
KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP (K093471)KARL STORZ Endoscopy-America, Inc.2010-10-18
KYPHON XPANDER II INFLATABLE BONE TAMP (K101864)Medtronic2010-10-14
AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM (K092723)Skeletal Dynamics, LLC2010-10-04
EBERLE SHAVER SYSTEM ACCESSORIES (K092977)Efs Eberle Feinwerktechnische Systeme2010-09-29
VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES (K101734)Visionscope Technologies, LLC2010-09-08
STRYKER ARTHROSCOPE (K093677)Stryker Endoscopy2010-03-05
C-MOR VISUALIZATION DEVICE (K093717)Axis Surgical Technologies, Inc.2010-03-02
POWERPUMP ARTHROSCOPY SYSTEM (K093409)Medical Vision AB2010-02-24
VERTOS MEDICAL MILD DEVICE KIT (K093062)X-Sten Corp.2010-02-04
INDISCAL ASPIRATION DEVICE AND ACCESSORIES (K092877)Baylis Medical Co., Inc.2009-11-17
MAXMORESPINE TOM STICK (K083552)Hoogland Spine Products, GmbH2009-10-09
SPINAL FORAMINOSCOPE (K082841)Blazejewski Medi-Tech GmbH2009-09-09
ARTHROSCOPE (K091398)Orthopedic Sciences, Inc.2009-08-26
ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE (K083707)Arthrex, Inc.2009-08-03
MAXMORESPINE SPINAL SYSTEM (K090132)Hoogland Spine Products, GmbH2009-06-09
PERCUTANEOUS DISCECTOMY SYSTEM (K090815)Laurimed, LLC2009-05-21
XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004 (K090303)Corespine Technologies, LLC2009-04-30
ENSPIRE DEBRIDER SYSTEM (K090278)Spine View, Inc.2009-04-15
ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) (K083161)Conmed Linvatec2009-03-27
TIGER DISCECTOMY DEVICE (K081240)Spinal Devices, LLC2009-02-27
VISIONSENSE STEREOSCOPIC VISION SYSTEM (K082355)Visionsense, Ltd.2008-12-15
SURGVIEW INTEGRATED VISUALIZATION SYSTEM (K082293)Biovision Technologies, LLC2008-09-09
LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 (K082194)Laurimed, LLC2008-08-28
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE (K081051)Spine View, Inc.2008-08-07
SOPRO 670 ARTHROSCOPIC PUMP (K080122)Sopro2008-07-11
POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES (K080617)Richard Wolf Medical Instruments Corp.2008-06-27
X-VOID, SPIDER (K072198)Sintea Biotech, Inc.2008-06-06
HENKE SASS WOLF OF AMERICA ARTHROSCOPE (K080560)Henke Sass Wolf of America, Inc.2008-03-18
INNERVUE DIAGNOSTIC SCOPE SYSTEM (K072879)Biomet Orthopedics, Inc.2008-01-14
ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 (K070021)Jg Medical Products, LLC2007-12-07
ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR (K070874)Arthro Kinetics, Inc.2007-11-02
MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL (K072706)Conmed Linvatec2007-10-24
SMITH & NEPHEW ARTHROSCOPE (K072675)Smith & Nephew, Inc.2007-10-15
CONMED LINVATEC SMART GUARD IRRIGATOR (K070233)Conmed Linvatec2007-04-02
CONMED LINVATEC 24K IRRIGATION SYSTEM (K063326)Conmed Linvatec2007-01-31
SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM (K062849)Smith & Nephew, Inc.2007-01-19
X-STEN MILD TOOL KIT, MODEL MTK-0001 (K062038)X-Sten Corp.2006-12-19
FLOSIMPLE ARTHROSCOPY PUMP A120 (K062380)W.O.M. World of Medicine AG2006-12-14
EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES (K061134)Efs Eberle Feinwerktechnische Systeme2006-09-01
ENDOSCOPIC SPINE SYSTEM (K061246)Arthro Kinetics, Inc.2006-08-23
MODIFICATION TO ENDIUS ATAVI SYSTEM (K061345)Endius, Inc.2006-06-06
REMA SHAVER BLADES (K060172)Rema Medizintechnik GmbH.2006-05-31
MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW (K060198)Linvatec Corp.2006-05-11
ATHROCARE TOPAZ ARTHROWANDS (K053567)Arthrocare Corp.2006-03-06
DISC-FX SYSTEM (K052241)Ellman International, Inc.2006-02-24
ENDIUS ATAVI SYSTEM (K053267)Endius, Inc.2006-01-13
OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM (K051656)Osteobiologics, Inc.2005-10-25
JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE (K051827)Joimax GmbH2005-08-12
SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM (K051326)Smith & Nephew, Inc.2005-06-15
SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS (K050580)Smith & Nephew Endoscopy, Inc.2005-04-20
EQUESTRA FLUID DELIVERY SYSTEM (K043568)Medtronic Sofamor Danek2005-01-25
SMITH & NEPHEW VIDEOARTHROSCOPE (K043395)Smith & Nephew, Inc.2005-01-12
X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM (K041824)Future Medical Systems, SA2005-01-07
ARTHROJET XT (K041233)Hydrocision, Inc.2004-07-28
EQUESTRA FLUID DELIVERY SYSTEM (K040483)Medtronic Sofamor Danek, Inc.2004-07-23
KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A (K041454)Kyphon, Inc.2004-07-09
SKY BONE EXPANDER SYSTEM (SKY SYSTEM) (K040612)Disc-O-Tech Medical Technologies, Ltd.2004-06-17
NUCLEOTOME PROBE SET, MODEL 21200 (K040919)Clarus Medical, LLC2004-06-01
SKY BONE EXPANDER SYSTEM (SKY SYSTEM) (K040939)Disc-O-Tech Medical Technologies, Ltd.2004-05-12
VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES (K041135)Depuy Mitek, A Johnson & Johnson Company2004-05-10
LINVATEC 10K IRRIGATION SYSTEM (K033573)Linvatec Corp.2004-02-11
SKY BONE EXPANDER SYSTEM (K034037)Disc-O-Tech Medical Technologies, Ltd.2004-01-28
ARTHOSCOPY PUMP A115 (K033927)W.O.M. World of Medicine AG2004-01-15
TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT (K032891)Trans1, Inc.2004-01-15
B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) (K032358)Disc-O-Tech Medical Technologies, Ltd.2003-12-17
DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE (K032473)Stryker Instruments2003-11-07
POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851 (K030082)Richard Wolf Medical Instruments Corp.2003-10-30
IRRIGATION SETS (K032832)Vital Concepts, Inc.2003-09-26
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 (K032529)Hydrocision, Inc.2003-09-16
ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00, (K031972)Asap Endoscopic Products GmbH2003-09-15
KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A (K032212)Kyphon, Inc.2003-09-15
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY (K031605)Smith & Nephew, Inc.2003-06-18
EXOJET TISSUE MANAGEMENT SYSTEM (K031406)Mitek Worldwide2003-05-30
ARTHROSCOPY PUMP, MODEL A107 (K030402)W.O.M. World of Medicine AG2003-04-17
KSEA POWERSHAVER SYSTEM S2 (K030009)Karl Storz Endoscopy2003-04-02
ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 (K024291)Arthrex, Inc.2003-03-20
VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW (K030096)Arthrex, Inc.2003-03-18
DYONICS POWER CONTROL UNIT (K030196)Smith & Nephew, Inc.2003-02-20
DAVOL ARTHROVENT OUTFLOW TUBING (K030307)Davol, Inc.2003-02-13
SOHNIKS (K023783)Sohniks Endoscopy, Inc.2003-02-07
ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183 (K023777)Arthronet Medical, Inc.2002-12-11
KSEA SPINOSCOPE (K023187)Karl Storz Endoscopy2002-12-02
ENDIUS ATAVI SYSTEM (K022199)Endius, Inc.2002-10-02
AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE (K020457)Axiamed, Inc.2002-09-26
ENDIUS FLEXTIP BLADE (K022578)Endius, Inc.2002-08-23
ENDIUS ATAVI SYSTEM (K021748)Endius, Inc.2002-06-26
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