FDA 510(k) clearances — page 429

176,542 clearances on record, most recent first.

Clearances — page 429

42,801–42,900 of 176,542

K122752 — FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARDBranan Medical Corp.·Product code JXN·2013-01-30
K122928 — DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGARayence Co., Ltd.·Product code MQB·2013-01-30
K123279 — MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDINAbbott Vascular·Product code LOX·2013-01-30
K123369 — ILUMIEN OPTISLightlab Imaging, Inc.·Product code NQQ·2013-01-30
K123444 — LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDERCovidien, Formerly Valleylab, A Division of Tyco H·Product code GEI·2013-01-30
K120603 — VARILIFT -CWenzel Spine·Product code ODP·2013-01-29
K121463 — IMMUNOCAP ALLERGEN K82Thermo Fisher Scientific·Product code DHB·2013-01-29
K122431 — HEARTSPAN STEERABLE INTRODUCER KITThomas Medical Products, Inc.·Product code DYB·2013-01-29
K122890 — INION CPS ORBITAL PLATESInion OY·Product code JEY·2013-01-29
K123067 — PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILYAbbott Vascular, Inc.·Product code DQX·2013-01-29
K123269 — PROCEDURE REHEARSAL STUDIOSimbionix , Ltd.·Product code LLZ·2013-01-29
K123349 — A-SCAN PLUS CONNECTAccutome, Inc.·Product code IYO·2013-01-29
K123358 — PACIFIC PLUSMedtronic Vascular·Product code LIT·2013-01-29
K123737 — BIOGRAPH MCT FAMILYSiemens Medical Solutions USA, Inc.·Product code KPS·2013-01-29
K123873 — CONTRAST ENHANCED DIGITAL MAMMOGRAPHYHologic, Inc.·Product code MUE·2013-01-29
K123894 — GE ECHOPACGe Vingmed Ultrasound AS·Product code LLZ·2013-01-29
K123901 — TRACTUS TISSUEMAPPER REVIEWER APPLICATIONTractus Corporation·Product code LLZ·2013-01-29
K124048 — IMAGEQUBEIntuitive Imaging Informatics, LLC·Product code LLZ·2013-01-29
K122156 — ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTYOrthocon, Inc.·Product code MTJ·2013-01-28
K123135 — AXERA 2 ACCESS SYSTEM MODEL AXE200Arstasis, Inc.·Product code DYB·2013-01-28
K123760 — MULTIPLE NAMEAssurguard Sdn. Bhd.·Product code LZA·2013-01-28
K113375 — ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIREEswallow USA·Product code GXY·2013-01-25
K121326 — LANTOS 3D EAR SCANNERLantos Technologies·Product code ERA·2013-01-25
K121446 — BACT/ALERT PF PLUS CULTURE BOTTLEbioMerieux, Inc.·Product code MDB·2013-01-25
K121455 — BACT/ALERT FN PLUS CULTURE BOTTLEbioMerieux, Inc.·Product code MDB·2013-01-25
K121670 — MEDYSSEY CANNULATED PEDICLE SCREWMedyssey Co, Ltd.·Product code NKB·2013-01-25
K121860 — ESA615Fluke Biomedical·Product code DRT·2013-01-25
K122125 — ASA LASER SH1El.En Electronic Engineering Spa·Product code ILY·2013-01-25
K122172 — SYSTEM 83 PLUSCustom Ultrasonics·Product code FEB·2013-01-25
K122793 — LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SETDiaSorin, Inc.·Product code CDZ·2013-01-25
K122797 — ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAWEthicon Endo-Surgery, LLC·Product code GEI·2013-01-25
K123008 — RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORINBionime Corporation·Product code NBW·2013-01-25
K123055 — SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.·Product code HRS·2013-01-25
K123096 — REPROCESSED VESSEL SEALERSterilmed, Inc.·Product code NUJ·2013-01-25
K123237 — ZERONA 2.0 LASERErchonia Corporation·Product code OLI·2013-01-25
K123560 — VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEMCodman & Shurtleff, Inc.·Product code HCG·2013-01-25
K123632 — 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035Spectranetics Corp.·Product code MCW·2013-01-25
K123917 — DECLIPSESPECT VIEWERSurgiceye GmbH·Product code IZD·2013-01-25
K123956 — POWER LED 175KARL STORZ Endoscopy-America, Inc.·Product code FCW·2013-01-25
K123966 — GLUCOSE METER-CHECK SOLUTION FOR BAYERBionostics, Inc.·Product code JJX·2013-01-25
K112120 — DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SETDiazyme Laboratories·Product code GHH·2013-01-24
K121800 — POINT 500 HD POINT500C HDPointnix Co., Ltd.·Product code MUH·2013-01-24
K122251 — VITRA MULTISPOTQuantel Medical·Product code GEX·2013-01-24
K122926 — SUREFLEX STEERABLE GUIDING SHEATH KITBaylis Medical Co., Inc.·Product code DYB·2013-01-24
K123071 — VASHE SKIN AND WOUND HYDROGELPuricore, Inc.·Product code FRO·2013-01-24
K123304 — SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIOIvoclar Vivadent, AG·Product code EBF·2013-01-24
K123325 — Medafor Direct Gas-Assisted Application SystemMedafor, Inc.·Product code GCJ·2013-01-24
K123334 — REPROCESSED STEERABLE INTRODUCERStryker Sustainability Solutions, Inc.·Product code DYB·2013-01-24
DEN130012 — FERRISCAN R2-MRI ANALYSIS SYSTEMResonance Health Analysis Services Pty, Ltd.·Product code PCS·2013-01-23
K112728 — HEPAIRX VENTILATING AIR PURIFIERAir Innovations, Inc.·Product code FRF·2013-01-23
K121810 — OSSEOSPEED ANGLED ABUTMENT EVAstra Tech AB·Product code NHA·2013-01-23
K121964 — MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10MLAugmenix, Inc.·Product code NEU·2013-01-23
K122290 — ENVITEC MYSIGN O OXYGEN MEASURING DEVICEEnvitec-Wismar GmbH·Product code CCL·2013-01-23
K123281 — ACCULIF TL-PEEK CAGECoalign Innovations, Inc.·Product code MAX·2013-01-23
K123310 — FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)Utah Medical Products, Inc.·Product code GEI·2013-01-23
K123401 — GAMMA3 AND T2 RECON TARGETING DEVICESStryker Trauma AG·Product code HSB·2013-01-23
K123579 — FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SLSmith & Nephew, Inc.·Product code MBI·2013-01-23
K123857 — DURABLUE STERILIZATION WRAPCardinal Health200, LLC·Product code FRG·2013-01-23
K123982 — TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+Encore Medical L.P.·Product code KWS·2013-01-23
K121269 — TBAMigada Plant·Product code FPA·2013-01-22
K121461 — BACT/ALERT FA PLUS CULTURE BOTTLEbioMerieux, Inc.·Product code MDB·2013-01-22
K122995 — INTENSE PULSED LIGHT (IPL) SYSTEMSBeijing Kes Biology Technology Co., Ltd.·Product code ONF·2013-01-22
K123314 — AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACEMedtronic, Inc.·Product code DTZ·2013-01-22
K123566 — SYNAPSE 3D COLON ANALYSISFujifilm Medical Systems U.S.A, Inc.·Product code LLZ·2013-01-22
K123577 — SYNGO.VIA MI WORKFLOWSSiemens Medical Solutions USA, Inc.·Product code LLZ·2013-01-22
K123718 — PERMASORB DISPOSABLE FIXATION DEVICEC.R. Bard, Inc.·Product code GDW·2013-01-22
K123967 — CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERSCatheter Connections, Inc.·Product code QBP·2013-01-22
K120464 — INNESIS PEEK CAGEBk Meditech, Co., Ltd.·Product code MAX·2013-01-18
K121592 — POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGSTekmedic (M) Sdn Bhd·Product code LZA·2013-01-18
K121739 — IVUE WITH NORMATIVE DATABASEOptovue, Inc.·Product code HLI·2013-01-18
K121762 — CARDIAC VXGe Medical Systems, LLC·Product code LLZ·2013-01-18
K122310 — GEMINUS FOSSA SPECIFIC PLATE SYSTEMSkeletal Dynamics, LLC·Product code HRS·2013-01-18
K122768 — GENESISDornier Medtech America, Inc.·Product code JAA·2013-01-18
K123098 — XGEO GC80Samsung Electronics Co., Ltd.·Product code KPR·2013-01-18
K123163 — NEUROPACE BURR HOLE COVER MODEL 8110NeuroPace, Inc.·Product code GXR·2013-01-18
K123231 — CALIBER SPACERSGlobus Medical, Inc.·Product code MAX·2013-01-18
K123299 — MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADSSt. Jude Medical Neuromodulation·Product code GZB·2013-01-18
K123300 — BD PEN NEEDLEBecton, Dickinson & CO·Product code FMI·2013-01-18
K123328 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACKNitrilist Gloves Manufacturing Sdn Bhd·Product code LZA·2013-01-18
K123813 — VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLEVasonova, Inc.·Product code OBJ·2013-01-18
K123828 — PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEMHitachi Aloka Medical, Ltd.·Product code IYN·2013-01-18
K123920 — SYNGO.VIASiemens AG Medical Solutions·Product code LLZ·2013-01-18
K102689 — CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEMConventus Orthopaedics·Product code HRS·2013-01-17
K121098 — HERO I DENTAL IMPLANT SYSTEMKj Meditech Co., Ltd.·Product code DZE·2013-01-17
K121421 — FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)Fresenius Medical Care North America, Design Cente·Product code ONW·2013-01-17
K121606 — RESORB-X GKLS-Martin L.P.·Product code GWO·2013-01-17
K121929 — ZEPHYR 'X-SERIES PATIENT TRANSFER SLEDDiacor, Inc.·Product code FRZ·2013-01-17
K122132 — AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAMMolnlycke Health Care·Product code OMP·2013-01-17
K122408 — POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN)Hongye Plastic Products Co., Ltd.·Product code LZA·2013-01-17
K122585 — CRUX VENA CAVA FILTER SYSTEMCrux Biomedical·Product code DTK·2013-01-17
K122788 — TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 ONorthstar Healthcare Holdings·Product code LYY·2013-01-17
K122951 — XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110Icad, Inc.·Product code JAD·2013-01-17
K123110 — PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301Surgical Innovations Plc·Product code GCJ·2013-01-17
K123417 — BRIVO MR355, OPTIMA MR360Ge Hangwei Medical Systems Co., Ltd.·Product code LNH·2013-01-17
K123612 — FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVAFujirebio Diagnostics,Inc.·Product code JJX·2013-01-17
K123734 — BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEMBecton Dickinson Infusion Therapy Systems, Inc.·Product code FOZ·2013-01-17
K123946 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETSCincinnati Sub-Zero Products, Inc.·Product code DWJ·2013-01-17
K124003 — MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBEMed-Fibers, Inc.·Product code GEX·2013-01-17
K113246 — OCS-BNibec Company, Limited·Product code NPM·2013-01-16
K121392 — NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREEExactech, Inc.·Product code LZO·2013-01-16

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