FDA 510(k) clearances — page 430

176,542 clearances on record, most recent first.

Clearances — page 430

42,901–43,000 of 176,542

K121570 — AURIGA QIStarmedtec GmbH·Product code GEX·2013-01-16
K123038 — SWISS LITHOBREAKERE.M.S Electro Medical Systems S.A·Product code FFK·2013-01-16
K123264 — DK-PTCA BALLOON CATHETERIntuit Medical, LLC·Product code LOX·2013-01-16
K123274 — PROGASTRO SSCS ASSAYGen-Probe Prodesse, Inc.·Product code PCH·2013-01-16
K123609 — MERIT HYDROPHILIC GUIDE WIREMerit Medical Systems, Inc.·Product code DQX·2013-01-16
K123671 — WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEMSanitas, Inc.·Product code DRG·2013-01-16
K123838 — PRO HMPV+ ASSAYGen-Probe Prodesse, Inc.·Product code OEM·2013-01-16
K123922 — SYNGO DYNAMICSSiemens Medical Solutions USA, Inc.·Product code LLZ·2013-01-16
K122873 — VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQSCaremed Supply, Inc.·Product code JOW·2013-01-15
K123004 — MIRA LASERSMira Lasers, LLC·Product code GEX·2013-01-15
K123408 — ERGO IMAGING SYSTEMDigirad Corp.·Product code IYX·2013-01-15
K123535 — ILAB ULTRASOUND IMAGING SYSTEMBoston Scientific Corp·Product code IYO·2013-01-15
K123788 — INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)Varian Medical Systems, Inc.·Product code IYE·2013-01-15
K123878 — PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSINGKci USA, Inc. (Kinetic Concepts, Inc.)·Product code OMP·2013-01-15
DEN130003 — XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)Luminex Molecular Diagnostics, Inc.·Product code PCH·2013-01-14
K121706 — FORA V10 BLOOD GLUCOSE MONITORING SYSTEMForacare, Inc.·Product code CGA·2013-01-14
K122708 — REMESENSE FOR SENSITIVE TEETHSylphar N.V.·Product code LBH·2013-01-14
K122870 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.·Product code JWH·2013-01-14
K123311 — QXMEDICAL ACCESS & SUPPORT CATHETERQxmedical, LLC·Product code DQY·2013-01-14
K123372 — ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott Laboratories·Product code JIX·2013-01-14
K123752 — ACCULIF TL AND PL CAGECoalign Innovations, Inc.·Product code MAX·2013-01-14
K123898 — VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEMVolcano Corporation·Product code IYO·2013-01-14
K123905 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and Prevention·Product code OQW·2013-01-14
K120949 — INFRASCANNERInfrascan, Inc.·Product code OPT·2013-01-11
K121254 — CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGECamber Spine Technologies·Product code MAX·2013-01-11
K121313 — MTF NEW BONE VOID FILLERMusculoskeletal Transplant Foundation·Product code MQV·2013-01-11
K121765 — SCULPTOR ROBOTIC GUIDANCE ARM (RGA)Stanmore Implants Worldwide , Ltd.·Product code OLO·2013-01-11
K122572 — ICAM FUNDUS CAMERAOptovue, Inc.·Product code HKI·2013-01-11
K122576 — TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANTStryker Neurovascular·Product code MJN·2013-01-11
K122685 — ANGIOSCULPT PTA SCORING BALLOON CATHETERAngioscore, Inc.·Product code PNO·2013-01-11
K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEMLorad, A Hologic Co.·Product code IZH·2013-01-11
K122866 — VIVIX-S WITH VXVUEVieworks Co., Ltd.·Product code MQB·2013-01-11
K122878 — HD-IVUS ULTRASOUND IMAGING SYSTEMSilicon Vally Medical Instruments, Inc.·Product code OBJ·2013-01-11
K123048 — PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PROAdvanced Instrumentations, Inc.·Product code MHX·2013-01-11
K123270 — POWEREASE SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code HBE·2013-01-11
K123302 — IB CLINICImaging Biometrics, LLC·Product code LLZ·2013-01-11
K123324 — SELECTRA 7F CATHETERSBiotronik, Inc.·Product code DQY·2013-01-11
K123327 — 1.5T GEM RT OPEN ARRAYGe Healthcare Coils (Usa Instruments, Inc.)·Product code MOS·2013-01-11
K123414 — SPECBOARD JR.Macbrud Corp., Medical Division·Product code IZH·2013-01-11
K123644 — VIZION + DRViztek, LLC·Product code MQB·2013-01-11
K123839 — WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200Ningbo Diaier Electronic Co., Ltd.·Product code DXN·2013-01-11
K121206 — DETECTForum Engineering Technologies, Ltd.·Product code LQY·2013-01-10
K121959 — EVIS EXERA III VIDEO SYSTEMOlympus Medical Systems Corp.·Product code EOQ·2013-01-10
K122077 — MANOMETERIntersurgical, Inc.·Product code CAP·2013-01-10
K122383 — EM3 AEM MONITOR AEM CONNECTORSEncision, Inc.·Product code GEI·2013-01-10
K122391 — MEDTRONIC XOMED, INC.Medtronic Xomed, Inc.·Product code LRK·2013-01-10
K122687 — BLOOD CULTURE HOLDERGreiner Bio-One North America, Inc.·Product code JKA·2013-01-10
K122771 — SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEMSpinal Elements, Inc.·Product code OVE·2013-01-10
K122922 — E-BEAM ND: YAG LASEREclipse Aesthetics, LLC·Product code GEX·2013-01-10
K123201 — AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALERMedtronic Advanced Energy, LLC·Product code GEI·2013-01-10
K123223 — EC SINGLE USE, POLYPECTOMY SNAREEndochoice, Inc.·Product code FDI·2013-01-10
K123342 — OPTETRAK LOGIC CRC TIBIAL INSERTExactech, Inc.·Product code JWH·2013-01-10
K123396 — I.FLEX BY TCSThermoplastic Comfort Systems, Inc.·Product code EBI·2013-01-10
K123438 — XENX STONE MANAGEMENT DEVICEXenolith Medical·Product code OCY·2013-01-10
K123516 — CRYO-TOUCH IVMyoscience, Inc.·Product code GXH·2013-01-10
K123845 — MESyneron Beauty , Ltd.·Product code ONF·2013-01-10
K123849 — NEW COMFORT-FIT DENTAL GUARDDen Tek Oral Care, Inc.·Product code OBR·2013-01-10
K123874 — INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL SBaxter Healthcare Corp·Product code FPA·2013-01-10
K123911 — SENOMARK ULTRA BREAST TISSUE MARKERC.R. Bard, Inc.·Product code NEU·2013-01-10
K121399 — LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD PLuminex Corp.·Product code NSU·2013-01-09
K122062 — APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHERGen-Probe, Inc.·Product code OUY·2013-01-09
K122336 — Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MMEleven Blade Solutions, Inc.·Product code MBI·2013-01-09
K122357 — MERITS MODEL P322FWD POWERED WHEELCHAIRMerits Health Products Co., Ltd.·Product code ITI·2013-01-09
K122704 — BEST LOCALIZATION NEEDLE WITH I-125 SEEDBest Medical Intl.·Product code KXK·2013-01-09
K122914 — AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESEMedtronic, Inc.·Product code DTN·2013-01-09
K123213 — BD PHASEAL CLOSED SYSTEM TRANSFER DEVICEBecton, Dickinson & CO·Product code ONB·2013-01-09
K123441 — STRYKER CROSSFLOW ARTHROSCOPY PUMPStryker Endoscopy·Product code HRX·2013-01-09
K123781 — TRANSTEK GLASS BODY FAT ANALYZERZhongshan Transtek Electronics Co., Ltd.·Product code MNW·2013-01-09
K123798 — LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAKBio-Rad Laboratories·Product code JJX·2013-01-09
K123863 — UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPSUcp Biosciences, Inc.·Product code DKZ·2013-01-09
K121261 — ASAP MUITISCOPEAsap Endoscopic Products GmbH·Product code HRX·2013-01-08
K121621 — SOLOCEMColtene/Whaledent AG·Product code EMA·2013-01-08
K122048 — COLLAGEN TENDON SHEET-DRotation Medical, Inc.·Product code FTM·2013-01-08
K122698 — AEQUALIS ASCEND FLEX SHOULDER SYSTEMTornier S.A.S.·Product code KWS·2013-01-08
K123180 — FALCON SPACERSynthes (USA) Products, LLC·Product code MAX·2013-01-08
K123371 — ALIGNRT PLUSVision RT Limited·Product code IYE·2013-01-08
K123476 — MEGA 5.5 SPINE SYSTEMLsk Biopartners, Inc.·Product code MNH·2013-01-08
K123847 — MALLEABLE TIP ENDOSCOPIC APPLICATORMicromedics, Inc.·Product code GCJ·2013-01-08
K123868 — INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SETBaxter Healthcare Corp·Product code FPA·2013-01-08
K121585 — TS IMPLANT SYSTEMOsstem Implant Co., Ltd.·Product code DZE·2013-01-07
K121752 — AVIE TOTAL HB TEST SYSTEMMec Dynamics Corp·Product code GKR·2013-01-07
K121991 — ENTEROCOCCUS QUICKFISH BCAdvandx, Inc.·Product code OAH·2013-01-07
K122288 — BRAINSWAY DEEP TMS SYSTEMBrainsway , Ltd.·Product code OBP·2013-01-07
K122643 — VANTAGE MODEL V5000, V5100, V5000C, V5100CMidmark Corp.·Product code MUH·2013-01-07
K113516 — THERASOM-CASTFamily Dental Services, P.C.·Product code LRK·2013-01-04
K113787 — DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESDefibtech, LLC·Product code MKJ·2013-01-04
K122592 — INSTINCT JAVA SYSTEMZimmer Spine·Product code MNH·2013-01-04
K122818 — OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPEOlympus Keymed (Medical & Industrial Equipment) LT·Product code KCT·2013-01-04
K122854 — ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCERArrow International (Subsidiary of Teleflex Inc.)·Product code DYB·2013-01-04
K122976 — BODY FAT SCALE MODEL SF-371Shenzhen Belter Health Measurement and Analysis TE·Product code MNW·2013-01-04
K123388 — K7C SPACERK7, LLC·Product code ODP·2013-01-04
K123731 — BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAYGlaxosmithkline Consumer Healthcare (Gskch)·Product code LFD·2013-01-04
K100695 — COLLADENTAL BARRIERCollamatrix, Inc.·Product code NPL·2013-01-03
K121108 — DOPPLEX ABILITYHuntleigh Healthcare·Product code JOM·2013-01-03
K121975 — AIRVO HUMIDIFIER MYAIRO HUMIDIFIERFisher & Paykel Healthcare, Ltd.·Product code BTT·2013-01-03
K122237 — BIOPHOTAS LIFELIGHTBiophotas, Inc.·Product code ILY·2013-01-03
K122483 — PEARL DIABETES MANAGEMENT SYSTEMAsante Solutions, Inc.·Product code LZG·2013-01-03
K122943 — MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGERMoor Instruments, Ltd.·Product code DPT·2013-01-03
K123102 — SOVEREIGN MINIAesculap, Inc.·Product code GCJ·2013-01-03
K123194 — JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088North American Rescue Products, Inc.·Product code DXC·2013-01-03

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