FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K191345 |
A.M. Surgical, Inc. |
Pegasus System |
07/17/2019 |
K961853 |
ACUFEX MICROSURGICAL, INC. |
PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER |
06/21/1996 |
K992621 |
ADVANCED DIAGNOSTICS & INTERVENTIONS |
ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES |
11/08/1999 |
K201113 |
Advanced Medical Systems Group SRL |
Resascope RS-01/B |
12/21/2020 |
K954652 |
AESCULAP, INC. |
AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS |
02/14/1996 |
K003740 |
AESCULAP, INC. |
MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION |
04/27/2001 |
K162070 |
AJU Pharm Co.,Ltd. |
JOINIX CANNULAR SYSTEM |
03/16/2017 |
K012605 |
ALLIANCE MEDICAL CORP. |
REPROCESSED ATHROSCOPICS BURS |
11/07/2001 |
K012652 |
ALLIANCE MEDICAL CORP. |
REPROCESSED DYONICS ARTHROSCOPIC BURS |
11/08/2001 |
K012635 |
ALLIANCE MEDICAL CORP. |
REPROCESSED STRYKER ARTHROSCOPIC SHAVERS |
11/07/2001 |
K012611 |
ALLIANCE MEDICAL, INC. |
REPROCESSED DYONICS ARTHROSCOPIC SHAVERS |
11/07/2001 |
K012630 |
ALLIANCE MEDICAL, INC. |
REPROCESSED LINVATEC ARTHROSCOPIC BURS |
11/09/2001 |
K012613 |
ALLIANCE MEDICAL, INC. |
REPROCSSED LINVATEC SHAVERS |
11/07/2001 |
K112548 |
ALTOMEC ENDOSCOPY INC |
ALTOMEC ARTHROSCOPE |
08/15/2012 |
K962330 |
AMERICAN MICROPTIKS, INC. |
AMO ARTHOSCOPES |
09/11/1996 |
K024291 |
ARTHREX, INC. |
ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 |
03/20/2003 |
K083707 |
ARTHREX, INC. |
ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE |
08/03/2009 |
K030096 |
ARTHREX, INC. |
VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW |
03/18/2003 |
K070874 |
ARTHRO KINETICS INC. |
ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR |
11/02/2007 |
K061246 |
ARTHRO KINETICS INC. |
ENDOSCOPIC SPINE SYSTEM |
08/23/2006 |
K962321 |
ARTHROCARE CORP. |
ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970 |
07/19/1996 |
K961747 |
ARTHROCARE CORP. |
ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODEL 970) |
07/15/1996 |
K011083 |
ARTHROCARE CORP. |
ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND |
06/28/2001 |
K053567 |
ARTHROCARE CORP. |
ATHROCARE TOPAZ ARTHROWANDS |
03/06/2006 |
K010811 |
ARTHROCARE CORP. |
PERC-D SPINEWAND |
05/30/2001 |
K023777 |
ARTHRONET MEDICAL, INC. |
ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183 |
12/11/2002 |
K031972 |
ASAP ENDOSCOPIC PRODUCTS GMBH |
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, |
09/15/2003 |
K121261 |
ASAP ENDOSCOPIC PRODUCTS GMBH |
ASAP MUITISCOPE |
01/08/2013 |
K020457 |
AXIAMED, INC. |
AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE |
09/26/2002 |
K093717 |
AXIS SURGICAL TECHNOLOGIES, INC |
C-MOR VISUALIZATION DEVICE |
03/02/2010 |
K092877 |
BAYLIS MEDICAL CO., INC. |
INDISCAL ASPIRATION DEVICE AND ACCESSORIES |
11/17/2009 |
K161878 |
Baylis Medical Company Inc. |
PORTAGE System |
09/26/2016 |
K072879 |
BIOMET ORTHOPEDICS, INC. |
INNERVUE DIAGNOSTIC SCOPE SYSTEM |
01/14/2008 |
K020761 |
BIOMET, INC. |
POWER TEK II |
04/03/2002 |
K180315 |
Biopsybell s.r.l. |
DISKOM |
03/26/2018 |
K141326 |
BIOVISION TECHNOLOGIES, LLC |
NEEDLE VIEW CH SCOPE KITS |
10/08/2014 |
K143705 |
BIOVISION TECHNOLOGIES, LLC |
NeedleCam HD Visualization System |
02/20/2015 |
K082293 |
BIOVISION TECHNOLOGIES, LLC |
SURGVIEW INTEGRATED VISUALIZATION SYSTEM |
09/09/2008 |
K972768 |
BLACKSTONE MEDICAL, INC. |
BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM |
09/25/1997 |
K082841 |
BLAZEJEWSKI MEDI-TECH GMBH |
SPINAL FORAMINOSCOPE |
09/09/2009 |
K131824 |
CAREFUSION |
AVAFLEX VERTEBRAL BALLOON SYSTEM |
10/03/2013 |
K151125 |
CAREFUSION |
AVAflex Vertebral Balloon System |
11/24/2015 |
K150523 |
CAREFUSION |
AVAmax Vertebral Balloon |
10/29/2015 |
K131820 |
CAREFUSION |
AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G |
10/04/2013 |
K203526 |
CIT Ortho |
C Scope Visualization System |
01/12/2021 |
K974579 |
CLARUS MEDICAL SYSTEMS, INC. |
PERCSCOPE MODEL 2600 |
02/18/1998 |
K040919 |
CLARUS MEDICAL, LLC. |
NUCLEOTOME PROBE SET, MODEL 21200 |
06/01/2004 |
K011454 |
CLARUS MEDICAL, LLC. |
SPINE SCOPE, MODEL 2180 |
12/13/2001 |
K964975 |
COHORT MEDICAL PRODUCTS GROUP, INC. |
COHORT DISCECTOMY SYSTEMS (CDS) |
02/24/1997 |
K182882 |
Conmed Corporation |
CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control |
11/14/2018 |
K063326 |
CONMED LINVATEC |
CONMED LINVATEC 24K IRRIGATION SYSTEM |
01/31/2007 |
K070233 |
CONMED LINVATEC |
CONMED LINVATEC SMART GUARD IRRIGATOR |
04/02/2007 |
K072706 |
CONMED LINVATEC |
MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL |
10/24/2007 |
K083161 |
CONMED LINVATEC |
ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) |
03/27/2009 |
K090303 |
CORESPINE TECHNOLOGIES, LLC |
XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004 |
04/30/2009 |
K000198 |
CORTEK ENDOSCOPY, INC. |
CORTEK ARTHROSCOPE |
04/11/2000 |
K030307 |
DAVOL, INC. |
DAVOL ARTHROVENT OUTFLOW TUBING |
02/13/2003 |
K964879 |
DAVOL, INC., SUB. C.R. BARD, INC. |
PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM |
03/04/1997 |
K131191 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS |
07/22/2013 |
K130169 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE |
05/01/2013 |
K130912 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
OMNICUT RESECTION BLADE |
06/14/2013 |
K041135 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES |
05/10/2004 |
K032358 |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) |
12/17/2003 |
K034037 |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
SKY BONE EXPANDER SYSTEM |
01/28/2004 |
K040612 |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
SKY BONE EXPANDER SYSTEM (SKY SYSTEM) |
06/17/2004 |
K040939 |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
SKY BONE EXPANDER SYSTEM (SKY SYSTEM) |
05/12/2004 |
K193608 |
Eberle GmbH & Co. KG |
EBERLE Shaver System C3 and Accessories |
01/15/2021 |
K003898 |
EBI, L.P. |
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM |
01/04/2001 |
K010179 |
EBI, L.P. |
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM |
02/09/2001 |
K092977 |
EFS EBERLE FEINWERKTECHNISCHE SYSTEME |
EBERLE SHAVER SYSTEM ACCESSORIES |
09/29/2010 |
K061134 |
EFS EBERLE FEINWERKTECHNISCHE SYSTEME |
EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES |
09/01/2006 |
K971083 |
ELECTRO-BIOLOGY, INC. |
ARTHROSCOPE |
06/23/1997 |
K982484 |
ELECTRO-BIOLOGY, INC. |
EBI VUECATH ENDOSCOPIC SPINAL SYSTEM |
10/08/1998 |
K990459 |
ELECTRO-BIOLOGY, INC. |
EBI VUECATH ENDOSCOPIC SYSTEN |
04/23/1999 |
K180766 |
Elliquence, LLC |
Endiscope, Endiscope Cervical |
06/11/2018 |
K052241 |
ELLMAN INTERNATIONAL, INC. |
DISC-FX SYSTEM |
02/24/2006 |
K964919 |
EMERALD MEDICAL, INC. |
EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM |
01/28/1997 |
K021748 |
ENDIUS, INC. |
ENDIUS ATAVI SYSTEM |
06/26/2002 |
K022199 |
ENDIUS, INC. |
ENDIUS ATAVI SYSTEM |
10/02/2002 |
K053267 |
ENDIUS, INC. |
ENDIUS ATAVI SYSTEM |
01/13/2006 |
K002437 |
ENDIUS, INC. |
ENDIUS ENDOSCOPIC ACCESS SYSTEM |
10/02/2000 |
K022578 |
ENDIUS, INC. |
ENDIUS FLEXTIP BLADE |
08/23/2002 |
K991794 |
ENDIUS, INC. |
ENDOSCOPIC SPINAL ACCESS SYSTEM |
08/13/1999 |
K983144 |
ENDIUS, INC. |
FLEXPOSURE RETRACTOR |
02/24/1999 |
K061345 |
ENDIUS, INC. |
MODIFICATION TO ENDIUS ATAVI SYSTEM |
06/06/2006 |
K994425 |
ENDIUS, INC. |
MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM |
02/16/2000 |
K992040 |
FIBER IMAGING TECHNOLOGIES, INC. |
FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES |
08/06/1999 |
K955500 |
FUTURE MEDICAL SYSTEMS, INC. |
FMS ARTHOPROBE |
02/05/1996 |
K002040 |
FUTURE MEDICAL SYSTEMS, INC. |
FMS SOLO |
09/11/2000 |
K041824 |
FUTURE MEDICAL SYSTEMS, SA |
X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM |
01/07/2005 |
K141557 |
GALLINI MEDICAL DEVICES, SRL |
HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR |
12/08/2014 |
K003831 |
GLOBAL ENDOSCOPY, INC. |
ARTHROSCOPES |
07/20/2001 |
K190598 |
Globus Medical Inc. |
CROSSWAY Spinal Access System |
04/05/2019 |
K222490 |
Hand Biomechanics Lab, Inc |
HBL Blade Assembly |
11/14/2022 |
K132883 |
HEMODIA S.A.S. |
HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) |
11/01/2013 |
K221919 |
Hemodia SAS |
DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets |
03/09/2023 |
K203480 |
Hemodia SAS |
DOUBLEFLO system |
04/05/2021 |
K192921 |
Hemodia SAS |
Zeos Aqua Vision Pump and tube |
10/09/2020 |
K080560 |
HENKE SASS WOLF OF AMERICA, INC. |
HENKE SASS WOLF OF AMERICA ARTHROSCOPE |
03/18/2008 |
K962075 |
HENKE SASS WOLF OF AMERICA, INC. |
HSW GMBH ARTHROSCOPE |
01/17/1997 |
K090132 |
HOOGLAND SPINE PRODUCTS GMBH |
MAXMORESPINE SPINAL SYSTEM |
06/09/2009 |
K083552 |
HOOGLAND SPINE PRODUCTS GMBH |
MAXMORESPINE TOM STICK |
10/09/2009 |
K041233 |
HYDROCISION, INC. |
ARTHROJET XT |
07/28/2004 |
K020688 |
HYDROCISION, INC. |
HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR |
04/03/2002 |
K982266 |
HYDROCISION, INC. |
HYDROCISION ARTHROJET SYSTEM |
09/25/1998 |
K993009 |
HYDROCISION, INC. |
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY |
10/25/1999 |
K002764 |
HYDROCISION, INC. |
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR |
11/24/2000 |
K032529 |
HYDROCISION, INC. |
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 |
09/16/2003 |
K200729 |
HydroCision, Inc. |
HydroCision SpineJet System |
04/16/2020 |
K190804 |
HydroCision, Inc. |
HydroCision TenJet Device |
06/05/2019 |
K182287 |
Imedicom Co., Ltd. |
MEDINAUT Plus |
04/06/2019 |
K151268 |
IMEDICOM CO., LTD. |
SPINAUT-V, SPINAUT-S, SPINAUT-I |
03/16/2016 |
K140903 |
INTEGRATED ENDOSCOPY, INC. |
NUVIS ARTHROSCOPE |
07/17/2014 |
K191594 |
Integrated Endoscopy, Inc. |
Nuvis Battery Arthroscope |
07/11/2019 |
K181982 |
IntraVu, Inc. |
MIDAScope and Introducer Kit, and MIDASystem |
08/21/2018 |
K200763 |
IZI Medical |
Osteo-site Vertebral Balloon |
08/12/2020 |
K070021 |
JG MEDICAL PRODUCTS LLC |
ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 |
12/07/2007 |
K223709 |
Jiangsu Changmei Medtech Co., Ltd. |
Kyphoplasty Balloon Catheter |
08/16/2023 |
K051827 |
JOIMAX GMBH |
JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE |
08/12/2005 |
K983142 |
KARL STORZ ENDOSCOPY |
KSEA C-MOUNT ARTHROSCOPES |
12/07/1998 |
K963524 |
KARL STORZ ENDOSCOPY |
KSEA LARGE JOINT ARTHROSCOPY SET |
11/14/1996 |
K030009 |
KARL STORZ ENDOSCOPY |
KSEA POWERSHAVER SYSTEM S2 |
04/02/2003 |
K023187 |
KARL STORZ ENDOSCOPY |
KSEA SPINOSCOPE |
12/02/2002 |
K955480 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
BOZOTTA REINSERTION FORCEPS |
02/09/1996 |
K983384 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
DCI ENDOSCOPE |
11/25/1998 |
K993540 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE |
11/22/1999 |
K961713 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY |
05/31/1996 |
K093471 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP |
10/18/2010 |
K961228 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KARL STORZ MAGNIFYING ARTHROSOCPES |
10/10/1996 |
K970055 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY |
03/05/1997 |
K963029 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE |
11/27/1996 |
K955652 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KARL STORZ TARGETING UNIT |
01/17/1996 |
K971649 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KSEA ARTHROPUMP PLUS |
10/29/1997 |
K991051 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KSEA EPIDUROSCOPE |
06/01/1999 |
K961244 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME |
05/07/1996 |
K010345 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS |
08/03/2001 |
K010987 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KSEA MINIATURE TELESCOPE AND ACCESSORIES |
06/19/2001 |
K001918 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KSEA PERCUTANEOUS FORAMINOSCOPY SET |
09/19/2000 |
K981251 |
KYPHON, INC. |
KYPHON INFLATABLE BONE TAMP |
07/02/1998 |
K032212 |
KYPHON, INC. |
KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A |
09/15/2003 |
K010246 |
KYPHON, INC. |
KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A |
02/14/2001 |
K041454 |
KYPHON, INC. |
KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A |
07/09/2004 |
K082194 |
LAURIMED LLC |
LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 |
08/28/2008 |
K090815 |
LAURIMED LLC |
PERCUTANEOUS DISCECTOMY SYSTEM |
05/21/2009 |
K983652 |
LINVATEC CORP. |
ABLATOR ELECTRODE |
03/23/1999 |
K961590 |
LINVATEC CORP. |
APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET |
10/08/1996 |
K990524 |
LINVATEC CORP. |
E9000 SYSTEM |
07/15/1999 |
K981636 |
LINVATEC CORP. |
INTEGRATED DRIVE/PUMP SYSTEM |
08/20/1998 |
K033573 |
LINVATEC CORP. |
LINVATEC 10K IRRIGATION SYSTEM |
02/11/2004 |
K060198 |
LINVATEC CORP. |
MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW |
05/11/2006 |
K013117 |
LINVATEC CORP. |
RESECTION ABLATOR |
11/29/2001 |
K002088 |
LINVATEC CORP. |
SHAVER ABLATOR |
03/06/2001 |
K971059 |
LINVATEC CORP. |
UNIVERSAL DRIVE SYSTEM |
06/18/1997 |
K981269 |
LINVATEC CORP. |
UNIVERSAL DRIVE SYSTEM |
06/24/1998 |
K970642 |
LUXTEC CORP. |
TENOSCOPE |
05/21/1997 |
K970562 |
LUXTEC CORP. |
TENOSNARE |
05/14/1997 |
K200067 |
Medacta International SA |
MectaScope System |
10/01/2020 |
K012640 |
MEDICAL INSTRUMENTS TECHNOLOGY, INC. |
ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS |
02/28/2002 |
K012624 |
MEDICAL INSTRUMENTS TECHNOLOGY, INC. |
REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS |
11/08/2001 |
K011202 |
MEDICAL SCIENTIFIC, INC. |
MSI BIPOLAR SHEATH |
12/31/2001 |
K093409 |
MEDICAL VISION AB |
POWERPUMP ARTHROSCOPY SYSTEM |
02/24/2010 |
K992474 |
MEDIFIX, INC. |
ARTHROSCOPE / MEDIFIX INC. |
09/23/1999 |
K113028 |
MEDISISS |
MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS |
12/20/2011 |
K971996 |
MEDIVISION SCOPE SERVICE CENTER, INC. |
MEDIVISION ARTHROSCOP |
07/31/1997 |
K171237 |
Medos International SARL |
FMS VUE II Fluid Management and Tissue Debridement System |
01/18/2018 |
K133941 |
MEDOS INTERNATIONAL SARL |
MITEK ARTHROSCOPES |
04/18/2014 |
K213978 |
Medos International, SARL |
TELIGEN System |
10/18/2022 |
K123771 |
Medtronic |
KYPHON EXPRESS II INFLATABLE BONE TAMPS |
12/21/2012 |
K101864 |
Medtronic |
KYPHON XPANDER II INFLATABLE BONE TAMP |
10/14/2010 |
K043568 |
MEDTRONIC SOFAMOR DANEK |
EQUESTRA FLUID DELIVERY SYSTEM |
01/25/2005 |
K040483 |
MEDTRONIC SOFAMOR DANEK, INC. |
EQUESTRA FLUID DELIVERY SYSTEM |
07/23/2004 |
K002931 |
MEDTRONIC SOFAMOR DANEK, INC. |
METRX SYSTEM |
11/24/2000 |
K103231 |
MEDTRONIC SPINE LLC |
KYPHON INFLATION SYRINGE |
01/24/2011 |
K010677 |
MEDTRONIC XOMED, INC. |
XPS 3000 SYSTEM |
05/07/2001 |
K151532 |
MEDTRONIC, INC. |
KYPHON ELEMENT Inflatable Bone Tamp |
07/23/2015 |
K191596 |
Merit Medical Systems, Inc. |
Arcadia Balloon Catheter |
10/09/2019 |
K003695 |
MICRO-MEDICAL DEVICES, INC. |
MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES |
02/14/2001 |
K211297 |
MicroAire Surgical Instruments |
SMARTRELEASE Endoscopic Soft Tissue Release System |
06/24/2021 |
K223406 |
MicroAire Surgical Instruments |
SmartRelease Endoscopic Soft Tissue Release System |
02/02/2023 |
K181819 |
MicroAire Surgical Instruments LLC |
SMARTRELEASE Endoscopic Soft Tissue Release System |
11/06/2018 |
K992876 |
MITEK PRODUCTS |
VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM |
09/24/1999 |
K002402 |
MITEK PRODUCTS |
VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM |
08/31/2000 |
K031406 |
MITEK WORLDWIDE |
EXOJET TISSUE MANAGEMENT SYSTEM |
05/30/2003 |
K170703 |
Modern Medical Equipment Manufacturing Limited |
Single Use Arthroscopic Electrode (with Pencil) |
05/31/2018 |
K990911 |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
MTP ARTHROPUMP DISPOSABLE TUBING SET |
06/03/1999 |
K122411 |
MYELOTEC |
J-SCOPE SYSTEM |
02/11/2013 |
K960194 |
MYELOTEC, INC. |
MYELOTEC MYELOSCOPE |
09/04/1996 |
K980734 |
MYELOTEC, INC. |
MYELOTEC VIDEO GUIDED CATHETER |
08/11/1998 |
K991656 |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
AED ARTHROSCOPE |
12/02/1999 |
K120553 |
NLT SPINE LTD |
ESPIN |
08/09/2012 |
K130057 |
NLT SPINE LTD |
ESPIN |
02/07/2013 |
K133061 |
NLT SPINE LTD |
ESPIN SYSTEM |
11/27/2013 |
K990324 |
NUVASIVE, INC. |
NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM |
10/05/1999 |
K992782 |
NUVASIVE, INC. |
NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES |
10/05/1999 |
K221142 |
OK MediNet Korea Co., Ltd. |
Kyphoplasty Balloon System |
04/21/2023 |
K160249 |
Olympus Winter & Ibe GmbH |
ULTRA Telescopes |
04/21/2016 |
K992583 |
OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. |
MASS (MICRO-ACCESS SPINE SYSTEM) |
10/29/1999 |
K953913 |
OPTUS, INC. |
OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES |
01/22/1996 |
K003893 |
ORATEC INTERVENTIONS, INC. |
VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X |
03/01/2001 |
K000691 |
ORATEC INTERVENTIONS, INC. |
VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS |
05/04/2000 |
K003198 |
ORATEC INTERVENTIONS, INC. |
VULCAN TAC PROBES, MODEL 911XXX |
08/29/2001 |
K091398 |
ORTHOPEDIC SCIENCES, INC |
ARTHROSCOPE |
08/26/2009 |
K133018 |
ORTHOPEDIC SCIENCES, INC |
OSI Q SYSTEM ARTHROSCOPES |
02/26/2014 |
K051656 |
OSTEOBIOLOGICS, INC. |
OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM |
10/25/2005 |
K122861 |
OUROBOROS MEDICAL |
XTOOL |
12/07/2012 |
K013513 |
PAIN CONCEPTS, INC. |
DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE |
01/17/2002 |
K223244 |
Pristine Surgical |
Pristine Arthroscopic Visualization System |
12/21/2022 |
K183165 |
Pristine Surgical |
Pristine Scope |
01/16/2019 |
K152511 |
PROSURG, INC |
Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula |
07/11/2016 |
K190201 |
Providence Medical Technology, Inc. |
CORUS Spinal System |
03/08/2019 |
K212636 |
Providence Medical Technology, Inc. |
CORUS Spinal System-X |
10/15/2021 |
K180876 |
Providence Medical Technology, Inc. |
DTRAX Spinal System |
05/18/2018 |
K001741 |
RADIONICS, INC. |
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM |
10/23/2000 |
K060172 |
REMA MEDIZINTECHNIK GMBH. |
REMA SHAVER BLADES |
05/31/2006 |
K172092 |
Renovo, Inc. |
Reprocessed Shavers/Burs |
10/04/2017 |
K990397 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
FLEXIBLE FIBERSCOPES & ACCESSORIES |
10/25/1999 |
K994363 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS) |
03/06/2000 |
K000046 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) |
03/30/2000 |
K960222 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
PERCUTANEOUS ENDOSCOPIC DISCECTOMY |
03/08/1996 |
K030082 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851 |
10/30/2003 |
K080617 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES |
06/27/2008 |
K984304 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
RIWO DRIVE GENERATOR |
08/12/1999 |
K973405 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
YEUNG ENDOSCOPIC SPINE SYSTEM |
03/13/1998 |
K130778 |
RZ MEDIZINTECHNIK GMBH |
DISCOSCOPES, CERVICAL ENDOSCOPES |
04/14/2014 |
K133682 |
SCHOLLY FIBEROPTIC GMBH |
SCHOELLY ARTHROSCOPE |
06/02/2014 |
K072198 |
SINTEA BIOTECH, INC. |
X-VOID, SPIDER |
06/06/2008 |
K092723 |
SKELETAL DYNAMICS, LLC |
AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM |
10/04/2010 |
K201349 |
Smith & Nephew |
Smith+Nephew Arthroscopes |
07/20/2020 |
K955914 |
SMITH & NEPHEW DYONICS, INC. |
LIMITED REUSE ARTHROSCOPIC BLADES |
02/08/1996 |
K964215 |
SMITH & NEPHEW ENDOSCOPY, INC. |
ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM |
12/20/1996 |
K050580 |
SMITH & NEPHEW ENDOSCOPY, INC. |
SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS |
04/20/2005 |
K003572 |
SMITH & NEPHEW, INC. |
DYONICS CONTROL RF SYSTEM |
02/15/2001 |
K970511 |
SMITH & NEPHEW, INC. |
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES |
08/12/1997 |
K981156 |
SMITH & NEPHEW, INC. |
DYONICS INTELIJET INFLOW/OUTFLOW CANNULA |
05/20/1998 |
K030196 |
SMITH & NEPHEW, INC. |
DYONICS POWER CONTROL UNIT |
02/20/2003 |
K031605 |
SMITH & NEPHEW, INC. |
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY |
06/18/2003 |
K971676 |
SMITH & NEPHEW, INC. |
LIMITED REUSE ENDOSCOPIC BLADES |
06/27/1997 |
K051326 |
SMITH & NEPHEW, INC. |
SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM |
06/15/2005 |
K171794 |
Smith & Nephew, Inc. |
Smith & Nephew 25 Fluid Management System |
06/27/2017 |
K072675 |
SMITH & NEPHEW, INC. |
SMITH & NEPHEW ARTHROSCOPE |
10/15/2007 |
K062849 |
SMITH & NEPHEW, INC. |
SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM |
01/19/2007 |
K192155 |
Smith & Nephew, Inc. |
Smith & Nephew DYONICS 25 Fluid Management System |
09/04/2019 |
K043395 |
SMITH & NEPHEW, INC. |
SMITH & NEPHEW VIDEOARTHROSCOPE |
01/12/2005 |
K001226 |
SMITH & NEPHEW, INC. |
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM |
06/26/2000 |
K971253 |
SMITH & NEPHEW, INC. |
VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS |
06/13/1997 |
K023783 |
SOHNIKS ENDOSCOPY, INC. |
SOHNIKS |
02/07/2003 |
K080122 |
SOPRO |
SOPRO 670 ARTHROSCOPIC PUMP |
07/11/2008 |
K081240 |
SPINAL DEVICES, LLC |
TIGER DISCECTOMY DEVICE |
02/27/2009 |
K090278 |
SPINE VIEW, INC. |
ENSPIRE DEBRIDER SYSTEM |
04/15/2009 |
K110992 |
SPINE VIEW, INC. |
ENSPIRE DEBRIDER SYSTEM |
10/21/2011 |
K120680 |
SPINE VIEW, INC. |
ENSPIRE DISCECTOMY SYSTEM |
06/26/2012 |
K122134 |
SPINE VIEW, INC. |
FLEXLITE CAMERA |
12/27/2012 |
K113362 |
SPINE VIEW, INC. |
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) |
02/10/2012 |
K121548 |
SPINE VIEW, INC. |
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) |
08/16/2012 |
K081051 |
SPINE VIEW, INC. |
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE |
08/07/2008 |
K012536 |
STERILMED, INC. |
REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES |
11/02/2001 |
K183470 |
Stryker |
Precision Ideal Eyes Arthroscopes |
01/07/2019 |
K202659 |
Stryker |
Stryker Arthroscope |
12/01/2020 |
K191259 |
Stryker Corp. |
Stryker CrossFlow Integrated Arthroscopy Pump |
07/12/2019 |
K162062 |
STRYKER CORPORATION |
AVAmax Vertebral Balloon, AVAflex Vertebral Balloon |
11/01/2016 |
K130430 |
STRYKER CORPORATION |
IVAS 10MM AND 15MM BALLOON CATHETER |
05/23/2013 |
K151932 |
STRYKER CORPORATION |
Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing |
03/31/2016 |
K172116 |
Stryker Corporation |
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) |
01/25/2018 |
K181752 |
Stryker Corporation |
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) |
12/21/2018 |
K093677 |
Stryker Endoscopy |
STRYKER ARTHROSCOPE |
03/05/2010 |
K123441 |
Stryker Endoscopy |
STRYKER CROSSFLOW ARTHROSCOPY PUMP |
01/09/2013 |
K982375 |
Stryker Endoscopy |
STRYKER HIP ARTHOROSCOPY SET |
10/02/1998 |
K963304 |
Stryker Endoscopy |
STRYKER TEMPEST ORTHOPEDIC PUMP |
01/22/1997 |
K963332 |
Stryker Endoscopy |
THERMO-PLASTIC SHAVER BLADES |
10/11/1996 |
K973195 |
Stryker Endoscopy |
TOTAL PERFORMANCE SYSTEM SHAVER |
10/24/1997 |
K032473 |
STRYKER INSTRUMENTS |
DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE |
11/07/2003 |
K960046 |
SURGICAL DYNAMICS, INC. |
SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE |
04/02/1996 |
K012667 |
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. |
REPROCESSED ARTHROSCOPIC SHAPERS |
06/03/2002 |
K993021 |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
METRX SYSTEM |
11/10/1999 |
K954016 |
T. KOROS SURGICAL INSTRUMENTS CORP. |
VIDEOSCOPE W/IRRIGATION SHEATH |
01/25/1996 |
K202027 |
Taeyeon Medical Co., Ltd. |
Balex bone Expander System |
02/03/2021 |
K982133 |
THE OLYMPUS OPTICAL CO. |
OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT |
10/22/1998 |
K121482 |
THEKEN SPINE LLC |
INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY |
08/28/2012 |
K032891 |
TRANS1, INC. |
TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT |
01/15/2004 |
K113352 |
TRANSCORP, INC. |
TRANSCORP SPINAL ACCESS SYSTEM |
04/16/2012 |
K162475 |
Trice Medical |
mi-eye 2, mi-eye 2 monitor |
09/16/2016 |
K141119 |
TRICE MEDICAL, INC. |
CAMERA ENABLED PROBE |
07/29/2014 |
K212556 |
Trice Medical, Inc. |
mi-eye 3 needlescope with cannula, mi-tablet 3 |
09/15/2021 |
K020083 |
TUTA HEALTHCARE PTY LIMITED |
TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 |
02/12/2002 |
K960805 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
ARTHOSCOPE |
04/10/1996 |
K002008 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SURGICAL DYNAMICS SPINAL RETRACTOR |
08/16/2000 |
K012346 |
VANGUARD MEDICAL CONCEPTS, INC. |
VANGUARD REPROCESSED ARTHROSCOPIC BLADES |
10/16/2001 |
K122662 |
VERTIFLEX, INC. |
VERTIFLEX DIRECT DECOMPRESSION SYSTEM |
11/13/2012 |
K181885 |
Viseon, Inc. |
Voyant System |
10/02/2018 |
K191579 |
Viseon, Inc. |
Voyant System |
07/11/2019 |
K101734 |
VISIONSCOPE TECHNOLOGIES, LLC |
VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES |
09/08/2010 |
K153548 |
VISIONSENSE LTD |
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM |
02/22/2016 |
K141002 |
Visionsense Ltd. |
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM |
06/26/2014 |
K082355 |
VISIONSENSE, LTD. |
VISIONSENSE STEREOSCOPIC VISION SYSTEM |
12/15/2008 |
K032832 |
VITAL CONCEPTS, INC. |
IRRIGATION SETS |
09/26/2003 |
K033927 |
W.O.M. WORLD OF MEDICINE AG |
ARTHOSCOPY PUMP A115 |
01/15/2004 |
K030402 |
W.O.M. WORLD OF MEDICINE AG |
ARTHROSCOPY PUMP, MODEL A107 |
04/17/2003 |
K062380 |
W.O.M. WORLD OF MEDICINE AG |
FLOSIMPLE ARTHROSCOPY PUMP A120 |
12/14/2006 |
K173311 |
W.O.M. World of Medicine GmbH |
ARTHRO-Pump PA304 |
05/09/2018 |
K962114 |
W.O.M. WORLD OF MEDICINE, GMBH |
ARTHRO-SURGIMAT |
08/22/1996 |
K983910 |
W.O.M. WORLD OF MEDICINE, GMBH |
ARTHRO-SURGIMAT-1500 |
11/25/1998 |
K990443 |
W.O.M. WORLD OF MEDICINE, GMBH |
ARTHRO-SURGIMAT-2000 ECU |
02/26/1999 |
K000153 |
W.O.M. WORLD OF MEDICINE, GMBH |
ARTHRO-SURGIMAT-A103 |
02/08/2000 |
K163037 |
WEMED BIO-TECH INC. |
Intra medullary endo-transilluminating device (iMET device) |
02/17/2017 |
K971781 |
WILSON GREATBATCH TECHNOLOGIES, INC. |
GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES |
11/21/1997 |
K093062 |
X-STEN CORP. |
VERTOS MEDICAL MILD DEVICE KIT |
02/04/2010 |
K062038 |
X-STEN CORP. |
X-STEN MILD TOOL KIT, MODEL MTK-0001 |
12/19/2006 |
K983025 |
XOMED, INC. |
XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT |
11/06/1998 |
K973499 |
XOMED, INC. |
XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM |
01/30/1998 |