FDA 510(k) clearances — page 434

176,542 clearances on record, most recent first.

Clearances — page 434

43,301–43,400 of 176,542

K122762 — ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATORMicrosulis Medical Limited·Product code NEY·2012-11-30
K122893 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)Geenli Plastic Co, Ltd.·Product code LYZ·2012-11-30
K122920 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)Hebei Leader Plastic Co., Ltd.·Product code LYZ·2012-11-30
K122999 — POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGSTop Glove Sdn. Bhd.·Product code LZA·2012-11-30
K123377 — TARGET DETACHABLE COILStryker Neurovascular·Product code HCG·2012-11-30
K123378 — SOLITAIRE 2 REVASCULARIZATION DEVICEMicro Therapeutics Dba Ev3 Neurovascular·Product code NRY·2012-11-30
K121501 — ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)Arrow International (Subsidiary of Teleflex Inc.)·Product code LJS·2012-11-29
K121566 — PLANER BT37 INCUBATORPlaner Plc·Product code MQG·2012-11-29
K121649 — CONSTRUX MINI PEEK TI SPACER SYSTEMOrthofix·Product code ODP·2012-11-29
K121847 — TITANInteracoustics A/S·Product code ETY·2012-11-29
K121927 — MICROSTREAM FILTERLINE ICUOridion Medical 1987 , Ltd.·Product code CCK·2012-11-29
K121995 — TS FIXTURE SYSTEMOsstem Implant Co., Ltd.·Product code DZE·2012-11-29
K122722 — COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160Roche Diagnostics·Product code DFC·2012-11-29
K123037 — LIGHTSCALPELLightscalpel, LLC·Product code GEX·2012-11-29
K123080 — CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTSChemtron Biotech, Inc.·Product code JXM·2012-11-29
K123207 — PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEMOsteomed LP·Product code MAX·2012-11-29
K121475 — TXCELL SCANNING LASER DELIVERY SYSTEMIridex Corp·Product code GEX·2012-11-28
K121775 — ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLERVital Signs, Inc., A GE Healthcare Company·Product code LGZ·2012-11-28
K122052 — MINIFIX BALL MINIFIX ONEBonafix Surgical and Dental Implants, LLC·Product code DZE·2012-11-28
K122161 — SJM CONFIRMSt Jude Medical·Product code MXC·2012-11-28
K122334 — CHECKMATE SMALL BONE FUSION SYSTEMArthrosurface, Inc.·Product code HRS·2012-11-28
K122420 — DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIADiazyme Laboratories·Product code MRG·2012-11-28
K122429 — VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUALObject Research Systems (Ors), Inc.·Product code LLZ·2012-11-28
K122495 — PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTORPerkinelmer, Inc.·Product code MQB·2012-11-28
K122543 — AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35MicroVention, Inc.·Product code KRD·2012-11-28
K123020 — BLIP MODEL BP-700WFCarematix, Inc.·Product code DXN·2012-11-28
K123035 — SEAL ONEPerouse Medical·Product code DXC·2012-11-28
K123119 — CERARESIN BONDShofu Dental Corporation·Product code KLE·2012-11-28
K123218 — ILLICO FS FACET FIXATION SYSTEMAlphatec Spine, Inc.·Product code MRW·2012-11-28
K123384 — AZUR CX DETACHABLE 18MicroVention, Inc.·Product code KRD·2012-11-28
K120651 — STABILIZ FIXATION SYSTEMStabiliz Orthopaedics, LLC·Product code HRS·2012-11-27
K120787 — MERETE LOCKING BONE PLATE SYSTEM IIIMerete Medical GmbH·Product code HRS·2012-11-27
K120862 — WATER BOTTLE CAP IRRIGATON SYSTEMEndochoice, Inc.·Product code FEQ·2012-11-27
K121093 — D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000Dxm Co., Ltd.·Product code EBZ·2012-11-27
K121346 — PICOSURE WORKSTATIONCynosure, Inc.·Product code GEX·2012-11-27
K121763 — MULTICROSS SUPPORT CATHETERRoxwood Medical, Inc.·Product code DQY·2012-11-27
K121989 — OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,Exactech, Inc.·Product code MQV·2012-11-27
K122561 — ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINCeremed , Inc.·Product code KHJ·2012-11-27
K122725 — TANDA PEARL, ULTRAWYTE, PEARLSyneron Beauty·Product code EEG·2012-11-27
K123379 — ABBOTT ARCHITECT FREE T4Abbott Laboratories·Product code CEC·2012-11-27
K112462 — KITAZATO OPU NEEDLEKitazato Medical Co., Ltd.·Product code MQE·2012-11-26
K120409 — PICCOLO COMPOSITE PLATE SYSTEMCarboFix Orthopedics , Ltd.·Product code HRS·2012-11-26
K120904 — POLARIS DIAL-A-DATE CONTACT LENS CASEReliance Design & Manufacture Corp.·Product code LRX·2012-11-26
K121171 — CUROS TIPIvera Medical, Inc.·Product code QBP·2012-11-26
K121816 — SENSUS ELECTRODENeurometrix, Inc.·Product code GXY·2012-11-26
K121363 — DIOWAVE LOW LEVEL COLD LASER SYSTEMTechnological Medical Advancments, Inc. (Tma)·Product code ILY·2012-11-23
K121874 — G7 ACETABULAR SYSTEMBiomet Manufacturing Corp·Product code PBI·2012-11-23
K120217 — SONICSTIMU COMBO THERAPEUTIC DEVICEShenzhen Dongdixin Technology Co., Ltd.·Product code IMG·2012-11-21
K120326 — AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGERadiometer Medical Aps·Product code JHX·2012-11-21
K121216 — STR GRAFTSoft Tissue Regeneration, Inc.·Product code OWW·2012-11-21
K121662 — VECTTOR VT-200Alan Neuromedical Technologies, LLC·Product code LIH·2012-11-21
K121811 — POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVESShen Wei (Usa), Inc.·Product code LZC·2012-11-21
K121953 — HEMASORB APPLYOrthocon, Inc.·Product code MTJ·2012-11-21
K121963 — PLANMED NUANCE DIGIGUIDEPlanmed OY·Product code MUE·2012-11-21
K122110 — ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEMACON Laboratories, Inc.·Product code CGA·2012-11-21
K122154 — POWERPLAY MUSCLE MASSAGERFig, LLC·Product code IRP·2012-11-21
K122305 — CORIN TRINITY-I ACETABULAR SHELLCorin USA·Product code LZO·2012-11-21
K122581 — MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254Concentric Medical, Inc.·Product code DQY·2012-11-21
K123015 — .DECIMAL PHOTON BLOCK.Decimal, Inc.·Product code IXI·2012-11-21
DEN100023 — AHIP INTERNAL TRIGGER POINT WAND MODEL: 1National Center For Pelvic Pain Research Devices,·Product code OSD·2012-11-20
K113315 — RUMBLE TUFFAcute Ideas Co. , Ltd.·Product code HGX·2012-11-20
K121085 — HET BIPOLAR LIGATOR SYSTEMHet Systems, LLC·Product code GEI·2012-11-20
K121220 — EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHTExactech, Inc.·Product code KWS·2012-11-20
K121234 — GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATINGW. L. Gore & Associates, Inc.·Product code DYB·2012-11-20
K121365 — THERMOFORMED MOUTHGUARDSGlidewell Laboratories-Sleep Devices Group·Product code MQC·2012-11-20
K121499 — FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEMFujifilm Medical System U.S.A., Inc.·Product code IZF·2012-11-20
K121546 — VITEK 2 GRAM NEGATIVE DOXYCYCLINEbioMerieux, Inc.·Product code LON·2012-11-20
K121603 — RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3Randox Laboratories, Ltd.·Product code JJY·2012-11-20
K121712 — AIRSTRIP RPM FOR LIFENET CONSULTAirstrip Technologies, Inc.·Product code MSX·2012-11-20
K121757 — HEALTHMATEFOREVERHealthmate International, LLC·Product code NUH·2012-11-20
K121846 — CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLEB.Braun Medical, Inc.·Product code BSP·2012-11-20
K121865 — ZOLL RESCUENET 12-LEADZOLL Medical Corporation·Product code MSX·2012-11-20
K121977 — PLASMAJET NEUTRAL PLASMA SURGERY SYSTEMPlasma Surgical Limited·Product code GEI·2012-11-20
K122229 — VICEROY SPINAL SYSTEMTorrey Spine·Product code NKB·2012-11-20
K122443 — UFIT TEN-10Biosign Technologies, Inc.·Product code DXN·2012-11-20
K122454 — FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTIONFujifilm Medical System U.S.A., Inc.·Product code KPR·2012-11-20
K122467 — 3M TRUE DEFINITION SCANNER3M Company·Product code NOF·2012-11-20
K122488 — AMIGO REMOTE CATHETER SYSTEM & ACCESSORIESCatheter Robotics, Inc.·Product code DXX·2012-11-20
K122573 — HI-TORQUE COMMAND GUIDE WIRE FAMILYAbbott Vascular, Inc.·Product code DQX·2012-11-20
K122596 — ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMSSmith & Nephew, Inc.·Product code HWC·2012-11-20
K122606 — PHT-6500; PHT-60CFO; PAX-I3DMtechgroup·Product code OAS·2012-11-20
K122772 — PENUMBRA DDC CATHETERSPenumbra, Inc.·Product code DQY·2012-11-20
K122931 — S-LOK PSS SYSTEMSpinal USA·Product code MNI·2012-11-20
K123039 — CDI BLOOD PARAMETER MONITORING SYSTEM 500Terumo Cardiovascular Systems Corp.·Product code DRY·2012-11-20
K123198 — LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHABio-Rad Laboratories·Product code JJY·2012-11-20
K123229 — REMOTE PRESENCE SYSTEM, MODEL RP-VITAIntouch Health, Inc.·Product code DRG·2012-11-20
K123297 — COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEMBiomet Manufactuting Corp.·Product code MBF·2012-11-20
K123375 — SYNGO.VIASiemens AG·Product code LLZ·2012-11-20
K123409 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNSurgical Specialties Corp. Dba Angiotech·Product code GAM·2012-11-20
K113567 — SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEMSynthes, Inc.·Product code JEY·2012-11-19
K120617 — PTFE SUPER SHEATH INTRODUCERMartech Medical Products·Product code DYB·2012-11-19
K120711 — NON-CONTACT THERMOMETERK-Jump Health Co., Ltd.·Product code FLL·2012-11-19
K121100 — VITEK 2 AST STREPTOCOCUS VANCOMYCINbioMerieux, Inc.·Product code LON·2012-11-19
K121494 — LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPINGAap Implantate AG·Product code HRS·2012-11-19
K121791 — ZOU ANTERIOR LUMBAR PLATE SYSTEMCorelink, LLC·Product code KWQ·2012-11-19
K122333 — MOBILECARE MONITORAframe Digital, Inc.·Product code DRG·2012-11-19
K122356 — ALIVECOR HEART MONITOR FOR IPHONEAliveCor, Inc.·Product code DPS·2012-11-19
K122440 — RESTORELLE LColoplast Corp.·Product code OTO·2012-11-19
K122538 — ACUMED PELVIC BONE PLATE SYSTEMAcumed, LLC·Product code HRS·2012-11-19
K122699 — SENTRYSUITE PRODUCT LINECarefusion Germany 234 GmbH·Product code BTY·2012-11-19

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