FDA.reportPublic FDA data

ArthroCare Corporation

Matched from indexed company URL: ARTHROCARE CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30065246183010813691ArthroCare Corporation1N2026-01-017000 W William Cannon Dr Austin TX US 78735

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1785291857467400K992040FLEXISCOPE II ARTHROSCOPES AND ACCESSORIESHRX1999-08-06
1785291143169571K254122FLOW FLEXTEND Wand (72290039)GEI2026-03-30
1785291190118126K253680LYNX COBLATION Laryngeal Wand (72290254)GEI2026-03-25
1785291230510370K240964FLOW 90? WandGEI2024-05-08
1785291467239922K232290INTELLIO SHIFT SystemGEI2023-12-11
1785291068324042K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)GEI2023-06-26
1785291167971066K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION SystemGEI2022-09-01
1785291088498162K210423Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis WandGEI2021-06-24
1785291557394300K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation SystemGEI2020-12-18
1785291093626520K192027WEREWOLF COBLATION System, COBLATION HALO WandGEI2019-12-20
1785291654002112K183346FLOW 90 WandGEI2019-01-24
1785291560182984K180848AMBIENT Super MULTIVAC 50 Wand with Integrated Finger SwitchesGEI2018-05-01
1785291115066776K172165Q-Fix Suture AnchorMBI2017-08-17
1785291535339986K163142SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and UnloaderGAT2017-01-06
1785292015842778K162126Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)GEI2016-09-29
1785291895639075K162074Werewolf RF20000 Controller, FLOW 50 WandGEI2016-08-22
1785292065338760K161481Ambient HipVac 50 Wand with Integrated Finger SwitchesGEI2016-10-21
1785291278664036K153675Paragon T2 Wand with Integrated CableGEI2016-01-15
1785291692766566K153669MultiFIX S Ultra Knotless Fixation SystemMBI2016-01-19
1785291652482797K153313SpeedLock Knotless Fixation SystemMBI2015-12-11
1785291641269657K153186Adjustable Fixation DeviceMBI2016-01-28
1785291683875164K151897MultiFIX® P Knotless Fixation DeviceMBI2015-08-06
1785291884299043K143235RF20000a Controller, FLOW 50 WandGEI2015-10-23
1785291408567239K143134NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV SystemLOD2015-03-05
1785291633707844K143100NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System GentaLOD2015-03-05
1785291373306106K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated CableGEI2014-11-19
1785291408007065K140992ARTHROCARE NASASTENT CMC NASAL DRESSINGLYA2014-06-16
1785291474117819K140521TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCHGEI2014-06-10
1785291609004926K133727Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTUMBI2014-01-16
1785291803713762K133606N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILLMBI2014-04-01
1785291690848317K131709SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENTLRC2013-10-04
1785291602172113K131205ARTHROCARE HEAD AND NECK COBLATION WANDGEI2013-08-09
1785291330358504K130354MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)LYA2013-05-29
1785291247996544K130196SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DRMBI2013-02-27
1785291153819738K123268SMARTSTITCH PERFECTPASSER SYSTEMGAT2012-11-07
1785291622336857K123240SPEEDLOCK HIP KNOTLESS FIXATION IMPLANTMBI2013-02-14
1785291263486853K122652ARTHROCARE TURBINATOR WANDGEI2013-07-02
1785291399855646K121351SINUS DILATION SYSTEMLRC2012-08-29
1785291365185789K111397TITAN TI SUTURE ANCHOR SYSTEMMBI2011-07-12
1785291237502136K1107815.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAPMBI2011-05-27
1785291225173499K101448OPUS SPEEDSCREW SYSTEMMBI2010-06-21
1785291978526697K101437SPEEDFIX SUTURE SYSTEMMBI2010-10-29
1785291319463081K100353SPINEWAND SURGICAL DEVICEGEI2010-05-13
1785291750121829K093844SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHORMAI2010-04-01
1785291281024113K093343GRAFTY QUICKSETMQV2010-04-22
1785291652071600K093165ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDSGEI2009-12-04
1785291595482230K091674ARTHROCARE COBLATOR IQ SYSTEMGEI2010-01-15
1785291498764096K090393ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144GEI2009-06-23
1785292027636597K090380MAGNUM M FIXATION DEVICEMBI2009-03-13
1785291054291476K083306MODIFICATION TO ARTHROCARE ARTHROWANDSGEI2008-12-10
1785291335575356K082750ENTACT SEPTAL STAPLER, MODEL 610-00100OLL2009-01-06
1785291278455395K082666ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDSGEI2008-10-15
1785291623347239K081893OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500HWC2008-10-01
1785291378556436K081497OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503)MBI2008-07-28
1785291625018637K080482ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01GEI2008-03-20
1785291353083804K080282ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;GEI2008-02-15
1785291917848963K070673FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTUREGAT2007-04-02
1785291219832978K070374ARTHROCARE ENT PLASMA WANDGEI2007-04-25
1785291378695670K063172ARTHROCARE CAVITY SPINEWANDGEI2007-04-27
1785291786719588K061259MODIFICATION TO ARTHROCARE PERC-D SPINEWANDGEI2006-05-18
1785291122888040K042914OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLEMBI2004-11-12
1785291113634700K042584OPUS MINIMAGNUM ANCHOR WITH INSERTERHWC2004-12-14
1785291888275911K042031OPUS SPEEDSTITCH SUTURE DEVICEGAT2004-10-19
1785291663351435K033584ARTHROCARE ARTHROWANDSGEI2003-11-28
1785291221134632K033509MODIFICATION TO VERSABOND BONE CEMENTLOD2003-11-28
1785291303291451K032504ARTHROCARE SYSTEMGEI2003-08-21
1785291826373840K031937ALANTECH GRAFT FIXATION SCREWHWC2003-09-04
1785291238122223K030954ARTHROCARE PERCD SPINEWANDGEI2003-04-16
1785291202459843K030108ARTHROCARE ENT COBLATOR SURGERY SYSTEMGEI2003-02-03
1785291468622701K022688VERSABOND AB BONE CEMENTLOD2004-04-29
1785291811591856K021519ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDSGEI2002-06-06
1785291033607716K011634ARTHROCARE CONTROLLER, MODEL H2000; ARTHROCARE CABLE, MODEL H0970-02; FOOTSWITCH, MODEL H2000-04; POWERCORD, MODEL H2000GEI2001-06-19
1785291667969228K011279ENTEC EVAC PLASMA WANDGEI2001-07-19
1785291894363052K011083ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWANDHRX2001-06-28
1785291476813227K001904ARTHROCARE FLOW CONTROL UNITGEI2000-07-17
1785292066192610K001160VERSABOND BONE CEMENTLOD2000-12-11
1785291171552177
1785291304177444
1785291495034689
1785291500173126
1785291612799697
1785291668947798
1785291913968417
1785291105855889
1785291382865851
1785291397262661
1785291472149315
1785291509914234
1785291786793921
1785291849089684
1785291933153809
1785292037920667
1785292039988755

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI412026-03-30
MBI162017-08-17
LOD52015-03-05
GAT42017-01-06
LYA32014-06-16
HWC32008-10-01
LRC22013-10-04
HRX22001-06-28
MQV12010-04-22
MAI12010-04-01
OLL12009-01-06

PMN#

144 records. Showing 1-40. Next