FDA 510(k) clearances — page 436

176,542 clearances on record, most recent first.

Clearances — page 436

43,501–43,600 of 176,542

K122389 — TRUSCULPTCutera, Inc.·Product code PBX·2012-11-02
K122401 — TANGO M2 BLOOD PRESSURE MONITORSuntech Medical, Inc.·Product code DXN·2012-11-02
K122436 — COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEMC.R. Bard, Inc.·Product code FTL·2012-11-02
K122636 — REVELATION POROUS COATED HIP STEM, SIZE 8Encore Medical L.P.·Product code LPH·2012-11-02
K122646 — DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0TInvivo Corporation·Product code MOS·2012-11-02
K122938 — FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCHCarl Zeiss Meditec, AG·Product code NFJ·2012-11-02
K123021 — BIOPLEX 2200 EBV IGM KITBio-Rad Laboratories·Product code LJN·2012-11-02
K123179 — AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLINGC.R. Bard, Inc.·Product code PAH·2012-11-02
K123185 — DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEMShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYO·2012-11-02
K123267 — SURFFLASH(R) PLUS SAFETY I.V. CATHETERKofu Factory of Terumo Corp.·Product code FOZ·2012-11-02
K112700 — FRONTIER SADL INTERBODY FUSION DEVICEFrontier Medical Devices, Inc.·Product code OVD·2012-11-01
K120350 — EXTENDED LIFE BATTERYAed Battery Exchange, LLC·Product code MKJ·2012-11-01
K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANTHowmedica Osteonics Corp.·Product code FWP·2012-11-01
K121560 — LEVANT, HOMEGLIDEThyssenkrupp Accessibility B.V.·Product code ILK·2012-11-01
K121793 — AN EVO 1, CS EVO 1, CONTACT MINI, APOLLONAudifon-USA, Inc.·Product code LXB·2012-11-01
K122115 — COLLAGEN DENTAL WOUND DRESSINGSCollagen Matrix, Inc.·Product code KGN·2012-11-01
K122294 — PRESSURIZED INFUSION PUMPMui Scientific·Product code FFX·2012-11-01
K122350 — TAP PAP NASAL PILLOW MASKAirway Management, Inc.·Product code BZD·2012-11-01
K122496 — AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMBio-Logic Systems Corp.·Product code EWO·2012-11-01
K122637 — LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999Stryker Spine·Product code FST·2012-11-01
K112121 — ERGOSELECT/GEErgoline GmbH·Product code ISD·2012-10-31
K113602 — AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEMAap Implantate AG·Product code HRS·2012-10-31
K121732 — CANOPY LAMINOPLASTY FIXATION SYSTEMGlobus Medical, Inc.·Product code NQW·2012-10-31
K121768 — COSENSECapnia, Inc.·Product code CCJ·2012-10-31
K121862 — REX ANTERIOR CERVICAL PLATE SYSTEMDio Medical Co., Ltd.·Product code KWQ·2012-10-31
K122078 — LOFRIC PRIMO, LOFRIC HYDRO-KITAstra Tech, Inc.·Product code EZD·2012-10-31
K122130 — WINX SLEEP THERAPY SYSTEMApnicure, Inc.·Product code OZR·2012-10-31
K122163 — CERTEX SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.·Product code MNI·2012-10-31
K122313 — STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEMStryker·Product code JEY·2012-10-31
K122314 — QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLYCayenne Medical, Inc.·Product code MBI·2012-10-31
K122395 — DEPUY AGILITY LP TOTAL ANKLE PROSTHESISDePuy Orthopaedics, Inc.·Product code HSN·2012-10-31
K122434 — MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GELMedtronic Xomed·Product code NHB·2012-10-31
K122478 — MODIFIED TREVO RETRIEVERConcentric Medical, Inc.·Product code NRY·2012-10-31
K122876 — MULTIFLEX TINNITUS TECHNOLOGYStarkey Laboratories·Product code KLW·2012-10-31
K121973 — BIOPRO HEMI-EDGE TOE SYSTEMBiopro, Inc.·Product code KWD·2012-10-30
K111588 — LEGACY-500Mt Tables, LLC·Product code JFB·2012-10-26
K112139 — THE CANARY SYSTEMQuantum Dental Technologies, Inc.·Product code NBL·2012-10-26
K113786 — SPERMFREEZE SOLUTIONVitrolife Sweden AB·Product code MQL·2012-10-26
K120127 — SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEMSwan Valley Medical, Incorporated·Product code KOB·2012-10-26
K120406 — ZOLL FULLY AUTOMATIC AED PLUSZoll Medical Corporation, World Wide Headquarters·Product code MKJ·2012-10-26
K120796 — SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKERSuperdimension, Inc.·Product code JAK·2012-10-26
K120930 — CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSINGMedtrade Products , Ltd.·Product code FRO·2012-10-26
K121201 — SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENSSt. shine Optical Co., Ltd.·Product code LPL·2012-10-26
K121561 — FLOW2, SWINGThyssenkrupp Accessibility B.V.·Product code ILK·2012-10-26
K121781 — ECHONAVIGATOR RELEASE 1Philips Medical Systems Nederland B.V.·Product code LLZ·2012-10-26
K122003 — RENEW INSERTRenew Medical, Inc.·Product code PBP·2012-10-26
K122137 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEMAccuray Incorporated·Product code IYE·2012-10-26
K122215 — NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)Carticept Medical, Inc.·Product code FRN·2012-10-26
K122325 — SKINTEMP IIHuman Biosciences, Inc.·Product code KGN·2012-10-26
K122446 — LIQUIDBAND FLOW CONTROLAdvanced Medical Solutions (Plymouth), Ltd.·Product code MPN·2012-10-26
K122472 — VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEMBio-Rad Laboratories, Inc., Clinical Systems Divis·Product code LCP·2012-10-26
K122642 — ABL90 FLEXRadiometer Medical Aps·Product code CHL·2012-10-26
K122985 — COLUMBUS REVISION KNEE SYSTEMAesculap Implant System, Inc.·Product code JWH·2012-10-26
K123001 — ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc.·Product code IYN·2012-10-26
K123024 — TORQUE DEVICEBoston Scientific Corporation·Product code DQX·2012-10-26
K113020 — IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISASImmco Diagnostics, Inc.·Product code MID·2012-10-25
K120785 — OMNI 3 OXYGEN SYSTEMCaire, Inc.·Product code CAW·2012-10-25
K120869 — ANCHOR-L LUMBAR CAGEStryker Spine·Product code OVD·2012-10-25
K121594 — COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)Tekmedic (M) Sdn Bhd·Product code LYY·2012-10-25
K121637 — AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USESunwell Biotech Co., Ltd.·Product code MEG·2012-10-25
K121921 — INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMSIntuitive Surgical, Inc.·Product code NAY·2012-10-25
K121993 — SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCTHeidelberg Engineering GmbH·Product code OBO·2012-10-25
K122262 — ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEMHaemonetics Corp.·Product code CAC·2012-10-25
K122299 — SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLARTransenterix, Inc.·Product code GCJ·2012-10-25
K122694 — GE 8CH FOOT ANKLE COILGe Hangwei Medical Systems Co., Ltd.·Product code MOS·2012-10-25
K122712 — DIGITAL ELECTROCARDIOGRAPHShenzhen Biocare Electronics Co., Ltd.·Product code DPS·2012-10-25
K122956 — FUSELOX LUMBAR INTERBODY FUSION DEVICECaptiva Spine·Product code MAX·2012-10-25
K122969 — CLICKFINE PEN NEEDLEP/L Biomedical·Product code FMI·2012-10-25
K122971 — CLICKFINE PEN NEEDLEP/L Biomedical·Product code FMI·2012-10-25
K122987 — STEALTH 360 ORBITAL PAD SYSTEMCardiovascular Systems, Inc.·Product code MCW·2012-10-25
K123043 — IRMA C02 MODEL 200101; IRMA AX 200601Phasein AB·Product code CCK·2012-10-25
K123141 — ENSEAL TRIO TISSUE SEALING DEVICEEthicon Endo-Surgery, LLC·Product code GEI·2012-10-25
K120765 — VITROS CHEMISTRY PRODUCTS ECO2 SLIDESOrtho-Clinical Diagnostics, Inc.·Product code KHS·2012-10-24
K121312 — INTRAMEDULLARY NAIL SYSTEMWeigao Orthopaedic Device Co., Ltd.·Product code HSB·2012-10-24
K121636 — ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERTTgm Medical, Inc.·Product code LPH·2012-10-24
K122053 — SHAPEMATCH CUTTING GUIDEStryker Corp.·Product code MBH·2012-10-24
K122241 — IMAGEN3DCardiovascular Imaging Technologies·Product code KPS·2012-10-24
K122284 — HOFFMANN 3Stryker Corp.·Product code KTT·2012-10-24
K122289 — IMAGE-COM 5.0Tomtec Imaging Systems GmbH·Product code LLZ·2012-10-24
K122292 — RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEMReliance Medical Systems, LLC·Product code KWP·2012-10-24
K122422 — PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCERCare Fusion·Product code PNG·2012-10-24
K122924 — CRE FIXED WIRE BALLON DILATION CATHETERBoston Scientific Corp·Product code KNQ·2012-10-24
K122972 — CDC ZIRCONIA BLANKSContinental Dental Ceramics, Inc. (Dba Continental·Product code EIH·2012-10-24
K122989 — BIOMET LATERAL SPACER SYSTEMBiomet Spine (Aka Ebi, LLC)·Product code MAX·2012-10-24
K123012 — SMITH & NEPHEW SMF HIP STEMSmith & Nephew, Inc.·Product code LPH·2012-10-24
K120545 — HX-461Seers Technology Co., Ltd.·Product code DXN·2012-10-23
K120832 — FORTEX PEDICLE SCREW SYSTEMX-Spine Systems, Inc.·Product code MNH·2012-10-23
K121551 — RESOLUTE FACET SCREW SYSTEMNeurostructures, LLC·Product code MRW·2012-10-23
K121657 — PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATORProton Systems·Product code IYE·2012-10-23
K121705 — GEOResmed, Ltd.·Product code BZD·2012-10-23
K121815 — NUVASIVE SAGE LATERAL PLATE SYSTEMNuvasive, Inc.·Product code KWQ·2012-10-23
K122028 — AURICAL HITGn Otometrics·Product code ETW·2012-10-23
K122092 — MEDRANGE ELECTROSURGICAL EXPANSION SYSTEMMedrange Corporation·Product code GEI·2012-10-23
K122280 — IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEMCyden Limited·Product code OHT·2012-10-23
K122523 — CARESTREAM VUE PACSCarestream Health, Inc.·Product code LLZ·2012-10-23
K122533 — OSSEOFLEX SB INFLATABLE BONE TAMPOsseon Therapeutics, Inc.·Product code NDN·2012-10-23
K123109 — ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICECovidien·Product code GDW·2012-10-23
K120728 — PHASIX PLUG AND PATCHC.R. Bard, Inc.·Product code OWT·2012-10-22
K120747 — XN CAL PFStreck·Product code KRX·2012-10-22
K122050 — CPRMETER CPR FEEDBACK DEVICELaerdal Medical A/S·Product code LIX·2012-10-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.