FDA 510(k) clearances — page 413

176,542 clearances on record, most recent first.

Clearances — page 413

41,201–41,300 of 176,542

K130685 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMYHitachi Chemical Diagnostics, Inc.·Product code JFJ·2013-08-09
K130821 — INTEL-GE CARE INNOVATIONS CONNECT RCMIntel-Ge Care Innovations, LLC·Product code DRG·2013-08-09
K130863 — FACET SCREW SYSTEMSpinal USA·Product code MRW·2013-08-09
K131029 — ACCU-CHEK AVIVA PLUS TEST STRIPRoche Diagnostics Operations, Inc.·Product code NBW·2013-08-09
K131205 — ARTHROCARE HEAD AND NECK COBLATION WANDArthroCare Corporation·Product code GEI·2013-08-09
K131279 — ICONACY I-HIP SYSTEMIconacy Orthopedic Implants, LLC·Product code LPH·2013-08-09
K131415 — LIVE VIEW PANEL (LVP)Neurotronics, Inc.·Product code OLV·2013-08-09
K131419 — ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEMI-Sens, Inc.·Product code NBW·2013-08-09
K131441 — LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM IIDiaSorin, Inc.·Product code LGD·2013-08-09
K131522 — CORE PEDICLE SCREW SYSTEMCore-Nexus·Product code MNI·2013-08-09
K132129 — PRODESSE PROFLU+ ASSAYGen-Probe Prodesse, Inc.·Product code OCC·2013-08-09
K132154 — CAPSURE PS SYSTEMSpine Wave, Inc.·Product code MNI·2013-08-09
K132165 — QLAB QUANTIFICATION SOFTWAREPhilips Ultrasound, Inc.·Product code LLZ·2013-08-09
K132226 — METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHTMerete Medical GmbH·Product code HRS·2013-08-09
DEN130005 — QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MSCenters for Disease Control and Prevention·Product code PDY·2013-08-08
K121610 — COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAYRoche Diagnostics Operations·Product code PDJ·2013-08-08
K123390 — PEDIGUARD NERVE DETECTOR SYSTEMSpineguard S.A.·Product code PDQ·2013-08-08
K130179 — MP VIAL ADAPTER 13MMMedimop Medical Projects, Ltd.·Product code LHI·2013-08-08
K130273 — PANPAC VAGINAL DILATORSPanpac Medical Corporation·Product code HDX·2013-08-08
K130820 — EXPANDABLE LUMBAR INTERBODY SYSTEMNu Vasive, Incorporated·Product code MAX·2013-08-08
K130846 — MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREENIndustrial Clothings, Ltd.·Product code LZA·2013-08-08
K131538 — CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEMCaptiva Spine·Product code MNH·2013-08-08
K131674 — PREBENT PLATING WITH VIRTUAL SURGICAL PLANNINGBiomet Microfixation·Product code JEY·2013-08-08
K131694 — NMI PORT II CATHETERNavilyst Medical, Inc.·Product code LJT·2013-08-08
K131744 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARETerumobct, Inc.·Product code LKN·2013-08-08
K131759 — METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEMTianjin Walkman Biomaterial Co., Ltd.·Product code HRS·2013-08-08
K131810 — OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEMOsseus Fusion Systems, LLC·Product code MNH·2013-08-08
K131869 — PTS-X SIZING BALLOON CATHETERNuMED, Inc.·Product code MJN·2013-08-08
K131945 — GE DATEX-OHMEDA AVANCE CS2Datex-Ohmeda·Product code BSZ·2013-08-08
K132090 — BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.·Product code DLJ·2013-08-08
K123904 — PROTHELIALMueller Medical International, LLC·Product code FRO·2013-08-07
K130148 — FOREIGN BODY HOODUnited States Endoscopy Group, Inc.·Product code FDS·2013-08-07
K130608 — QUADCUTMedtronic Navigation, Inc.·Product code HAW·2013-08-07
K130932 — FIREBIRD SPINAL FIXATION SYSTEMOrthofix, Inc.·Product code NKB·2013-08-07
K131313 — ACTIVE BREATHING COORDINATORAktina Medical Corp.·Product code IYE·2013-08-07
K131345 — TIARRAY DENTAL IMPLANT SYSTEMNasseo, Inc.·Product code DZE·2013-08-07
K131360 — INTEGRA TITANIUM BONE WEDGEAscension Orthopedic·Product code HRS·2013-08-07
K131512 — KATIA SYSTEMShanghai Sanyou Medical Co, Ltd.·Product code KWQ·2013-08-07
K131642 — RSH BILIARY STONE REMOVAL DEVICERsh, LLC·Product code LQR·2013-08-07
K131722 — I.T.S. EXTREMITY FIXATION SYSTEMSI.T.S. GmbH·Product code HRS·2013-08-07
K132256 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+BBecton, Dickinson and Company·Product code PSZ·2013-08-07
K132259 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+BBecton, Dickinson and Company·Product code PSZ·2013-08-07
K122337 — OVUSENSEFertility Focus, Ltd.·Product code LHD·2013-08-06
K123047 — BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SETBracco Diagnostic, Inc.·Product code FCX·2013-08-06
K130046 — CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLC·Product code HIB·2013-08-06
K130126 — SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEMBiomet, Inc.·Product code MBF·2013-08-06
K130743 — THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLOrtho Kinematics, Inc.·Product code LLZ·2013-08-06
K131450 — FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0Ostial Corporation·Product code LOX·2013-08-06
K131875 — MENICON NECT CONTACT LENS CASEForesight Regulatory Strategies·Product code LRX·2013-08-06
K132111 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek USA·Product code NKB·2013-08-06
K122553 — MISSION PLUS HB HEMOGLOBIN TESTING SYSTEMACON Laboratories, Inc.·Product code GKR·2013-08-05
K122610 — PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.·Product code BYE·2013-08-05
K122883 — EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEMStelkast Company·Product code JWH·2013-08-05
K130342 — SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKERSauflon Pharmaceuticals, Ltd.·Product code LPL·2013-08-05
K130541 — SYMMETRY KERRISON DISPOSABLE TIP RONGEURSSymmetry Surgical·Product code HAE·2013-08-05
K131286 — PRIMATRIX DERMAL REPAIR SCAFFOLDTei Biosciences, Inc.·Product code KGN·2013-08-05
K131704 — EPIDOSESun Nuclear Corporation·Product code IYE·2013-08-05
K131930 — JBAIDS ANTHRAX DETECTION KITBiofire Diagnostics, Inc.·Product code NHT·2013-08-05
K132190 — EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOMELeMaitre Vascular, Inc.·Product code MGZ·2013-08-05
K130748 — SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0Smith & Nephew, Inc.·Product code OLO·2013-08-04
K121370 — VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLEVectec·Product code FHO·2013-08-02
K122063 — INTELLISAVE AX700 ANESTHESIA SYSTEMPhilips Anesthesia Care·Product code BSZ·2013-08-02
K123347 — NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0Normed Medizin-Technik GmbH·Product code HRS·2013-08-02
K130933 — SOLUTISQuantel Medical·Product code HQF·2013-08-02
K131166 — SOFIA(R) HCG FIAQuidel Corp.·Product code JHI·2013-08-02
K131301 — BD FACS SAMPLE PREP ASSISTANT IIIBecton, Dickinson & CO·Product code PER·2013-08-02
K131493 — SIDEKICK AND USHER SUPPORT CATHETERSC.R. Bard, Inc.·Product code DQY·2013-08-02
K131517 — MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBINGMedrad, Inc. / Bayer Medical Care, Inc.·Product code FPK·2013-08-02
K132061 — RESTORELLE M, RESTORELLE XLColoplast Corp.·Product code OTO·2013-08-02
K123399 — MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.·Product code IKN·2013-08-01
K123571 — CARDIO VISION MICS AORTIC CLAMPSCardiomedical GmbH·Product code DXC·2013-08-01
K130033 — TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TOBiomet Manufacturing Corp·Product code MBI·2013-08-01
K130109 — ENDOGRAPH DCVilla Sistemi Medicali S.P.A.·Product code EHD·2013-08-01
K130140 — INTRA-LOCK OP DENTAL IMPLANTIntra-Lock International·Product code DZE·2013-08-01
K130345 — AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMINGMayer Laboratories, Inc.·Product code NUC·2013-08-01
K130814 — RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company·Product code MBI·2013-08-01
K130826 — PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUERStryker Endoscopy·Product code GCJ·2013-08-01
K131079 — CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRICCreganna Medical Devices·Product code DYB·2013-08-01
K131305 — CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBEChison Medical Imaging Co., Ltd.·Product code IYN·2013-08-01
K123908 — OMNIPORE SURGICAL IMPLANTS AND ACCESSORIESMatrix Surgical USA·Product code KKY·2013-07-31
K130144 — ABL90 FLEXRadiometer Medical Aps·Product code CHL·2013-07-31
K130181 — GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMInfopia Co, Ltd.·Product code NBW·2013-07-31
K130923 — 5F DIGNITY CT TITANIUM PORTMedical Components, Inc.·Product code LJT·2013-07-31
K131729 — JBAIDS PLAGUE DETECTION KITBiofire Diagnostics, Inc.·Product code OIH·2013-07-31
K131754 — WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)Guangzhou Wondfo Biotech Co., Ltd.·Product code DIO·2013-07-31
K131936 — JBAIDS TULAREMIA DETECTION KITBiofire Diagnostics, Inc.·Product code OEH·2013-07-31
K131942 — NMI PICC III CATHETER, NMI HPICC III CATHETERNavilyst Medical, Inc.·Product code LJS·2013-07-31
K132040 — VIAL CONNECTOR 13MM CLOSED COLLARMedimop Medical Projects, Ltd.·Product code LHI·2013-07-31
K132041 — REXTAR XMeta Biomed, Inc.·Product code EHD·2013-07-31
K132043 — ARTHREX SPEEDCINCHArthrex, Inc.·Product code GAT·2013-07-31
K122458 — VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEMCello Partnership D/B/A Verizon Wireless·Product code DRG·2013-07-30
K122532 — DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIESIntuitive Surgical, Inc.·Product code NAY·2013-07-30
K124000 — MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEMMedapps Inc., Dba Alere Connect·Product code DRG·2013-07-30
K130302 — SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXATSpinevision S.A.·Product code MNI·2013-07-30
K130621 — BROADMASTER HEALTHCARE SYSTEMBroadmaster Biotech Corporation·Product code NBW·2013-07-30
K130949 — CP4 OSSEOTITE CERTAIN DENTAL IMPLANTSBiomet 3i·Product code DZE·2013-07-30
K131150 — CURA COMPENSATORCura Medical Technologies, LLC·Product code IXI·2013-07-30
K131449 — COALITION SPACERGlobus Medical, Inc.·Product code OVE·2013-07-30
K131955 — NEUROBLATE(TM) SYSTEMMonteris Medical, Inc.·Product code GEX·2013-07-30
K132008 — 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAPMedtronic, Inc.·Product code DTD·2013-07-30

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