FDA 510(k) clearances — page 383

176,542 clearances on record, most recent first.

Clearances — page 383

38,201–38,300 of 176,542

K141663 — EEVA DISH (WITH 12 MICROWELLS)Auxogyn, Inc.·Product code MQK·2014-07-22
K141677 — VARIAX ELBOW PLATING SYSTEMStryker Trauma AG·Product code HRS·2014-07-22
K141678 — EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEMAbbott Vascular·Product code NTE·2014-07-22
K133419 — BABYMEG BIOMAGNETOMETER SYSTEMTristan Technologies, Inc.·Product code OLY·2014-07-21
K134031 — THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETERBoston Scientific Corporation·Product code LOX·2014-07-21
K140726 — CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIVBoston Scientific Corp·Product code FDI·2014-07-21
K140879 — BIOSURE HEALICOIL PK INTERFERENCE SCREWSmith & Nephew, Inc.·Product code MBI·2014-07-21
K140915 — EXCIA TOTAL HIP SYSTEMAesculap Implant Systems, LLC·Product code LZO·2014-07-21
K141034 — AZUL PERSONAL LUBRICANTChurch & Dwight Co., Inc.·Product code NUC·2014-07-21
K132732 — MEDYSSEY ANTERIOR CERVICAL FUSION CAGEMedyssey USA, Inc.·Product code ODP·2014-07-18
K133233 — PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDEPjur Group Luxembourg S.A.·Product code NUC·2014-07-18
K133551 — ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEMZimmer Dental, Inc.·Product code NHA·2014-07-18
K133699 — POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVESPt. Smartglove Indonesia·Product code LZA·2014-07-18
K140005 — ALMA DIODE TABLETOP LASERAlma Lasers , Ltd.·Product code GEX·2014-07-18
K140082 — AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEMTornier S.A.S.·Product code PHX·2014-07-18
K140200 — E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODESNeuroinvent, Inc.·Product code GXZ·2014-07-18
K140518 — GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETERGeistlich Pharma AG·Product code NPL·2014-07-18
K140845 — LEVO TINNITUS MASKING SOFTWARE DEVICEOtoharmonics Corp·Product code KLW·2014-07-18
K140897 — SYNGO.MR NEUROLOGY, SYNGO.MMR GENERALSiemens Medical Solutions USA, Inc.·Product code LLZ·2014-07-18
K141100 — OPTILITE C1 INACTIVATOR KITThe Binding Site Group , Ltd.·Product code DBA·2014-07-18
K141118 — NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETEREv3, Inc.·Product code LIT·2014-07-18
K141219 — JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITSBiomet Manufacturing Corp·Product code HTN·2014-07-18
K141265 — ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KITElitechgroup·Product code JHW·2014-07-18
K141280 — ILENS (OCUFILCON D) DAILY SOFT CONTACT LENSSeinoh Optical Co. , Ltd.·Product code LPL·2014-07-18
K141430 — VARIAX DISTAL RADIUS PLATING SYSTEMStryker Leibinger GmbH & Co KG·Product code HRS·2014-07-18
K141577 — ARTHREX PIP DARTArthrex, Inc.·Product code HTY·2014-07-18
K141625 — POLYSYN SURGICAL SUTURESurgical Specialties Corp·Product code GAM·2014-07-18
K141639 — VOLUSON S6, VOLUSON S8GE Healthcare·Product code IYN·2014-07-18
K141641 — ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEMZonare Medical Systems, Inc.·Product code IYN·2014-07-18
K141654 — THE BELMONT RAPID INFUSERBelmont Instrument Corporation·Product code FRN·2014-07-18
K131757 — TATTOOSTAR EFFECT COMBOAsclepion Laser Technologies GmbH·Product code GEX·2014-07-17
K140499 — VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSESSTERIS Corporation·Product code FRC·2014-07-17
K140504 — ACCUCATH BC INTRAVASCULAR CATHETER SYSTEMVascular Pathways, Inc.·Product code FOZ·2014-07-17
K140515 — VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABELSTERIS Corporation·Product code JOJ·2014-07-17
K140682 — FINGERTIP PULSE OXIMETERBeijing Choice Electronic Technololgy Co., Ltd.·Product code DQA·2014-07-17
K140750 — SHILLA GROWTH GUIDANCE SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code PGM·2014-07-17
K140757 — D2 HEMOSTANTIC DRESSINGZ-Medica, LLC·Product code QSY·2014-07-17
K140825 — DELWORKS DR SYSTEMDel Medical, Inc.·Product code MQB·2014-07-17
K140903 — NUVIS ARTHROSCOPEIntegrated Endoscopy, Inc.·Product code HRX·2014-07-17
K141143 — COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SETRoche Diagnostics·Product code NDY·2014-07-17
K141647 — HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)Healgen Scientific,, LLC·Product code DIO·2014-07-17
K133568 — G-TLVitrolife, Inc.·Product code MQL·2014-07-16
K140142 — CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)Choicespine, LP·Product code MAX·2014-07-16
K140558 — PROCTIGARDAccess Pharmaceuticals, Inc.·Product code PHN·2014-07-16
K140714 — PORCINE ANORGANIC BONE MINERALCollagen Matrix, Inc.·Product code NPM·2014-07-16
K140844 — BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CCSynergy Biomedical, Inc.·Product code MQV·2014-07-16
K141000 — SENSITITRE SUSCEPTIBILITY PLATESThermo Fisher Scientific·Product code JWY·2014-07-16
K141112 — STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETERBoston Scientific·Product code LIT·2014-07-16
K141217 — ACCULIF TL AND PL CAGEStryker Corporation·Product code MAX·2014-07-16
K141563 — SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGCRayence Co., Ltd.·Product code MQB·2014-07-16
K141566 — SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCCRayence Co., Ltd.·Product code MQB·2014-07-16
K132856 — HEARTWAY POWER WHEELCHAIRHeartway Medical Products Co., Ltd.·Product code ITI·2014-07-15
K133053 — MILESTONE SPINAL SYSTEMWeigao Orthopaedic Device Co., Ltd.·Product code MAX·2014-07-15
K133813 — FLXFIT INTERVERTEBRAL BODY FUSION DEVICEExpanding Orthopedics, Inc.·Product code MAX·2014-07-15
K133890 — AESCULAP OPTILENE NONABSORBABLE SUTUREAesculap, Inc.·Product code GAW·2014-07-15
K140615 — VICTUS FEMTOSECOND LASER PLATFORMTechnolas Perfect Vision GmbH·Product code OOE·2014-07-15
K140753 — ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEMMedivators·Product code OCX·2014-07-15
K140789 — CORMATRIX ECM FOR VASCULAR REPAIRCormatrix Cardiovascular, Inc.·Product code DXZ·2014-07-15
K140813 — REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVESCovidien·Product code JOW·2014-07-15
K140826 — GMK SPHERE EXTENSIONMedacta International·Product code JWH·2014-07-15
K141063 — LINSCAN 808, LINSCAN 980Gme (German Medical Engineering) GmbH·Product code GEX·2014-07-15
K141609 — PULSTAR LOGIX PUMPAlbahealth, LLC·Product code JOW·2014-07-15
K132765 — PFX SPINOUS PROCESS FIXATION SYSTEMInnovasis, Inc.·Product code PEK·2014-07-14
K133919 — CONSENSUS VITALITE TIBIAL INSERTConsensus Orthopedics, Inc.·Product code JWH·2014-07-14
K140829 — UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENTBeckman Coulter, Inc.·Product code LCP·2014-07-14
K141532 — CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINEGuangzhou Wondfo Biotech Co., Ltd.·Product code DKZ·2014-07-14
K141605 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code NKB·2014-07-14
K131094 — VIMOVEDorsa VI Pty., Ltd.·Product code IKN·2014-07-11
K131513 — SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILYRitm Okb Zao·Product code GZJ·2014-07-11
K132806 — FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECEFotona D.D.·Product code GEX·2014-07-11
K133676 — ABX PENTRA MICRO ALB CONTROL L/HHORIBA ABX SAS·Product code JJY·2014-07-11
K140186 — THE STORK OTCRinovum Women'S Health, Inc.·Product code OBB·2014-07-11
K140316 — EXAMINATION GLOVESHl Rubber Industries Sdn Bhd·Product code LZA·2014-07-11
K140451 — KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION)Keeler Limited·Product code HJO·2014-07-11
K140459 — ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEMConmed Corporation·Product code GEI·2014-07-11
K140830 — EXPRT REVISION KNEEEncore Medical L.P.·Product code JWH·2014-07-11
K140998 — PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COILQuality Electrodynamics, LLC·Product code MOS·2014-07-11
K141301 — MAXLOCK EXTREME ELBOW FRACTURE SYSTEMOrthohelix Surgical Designs, Inc.·Product code HRS·2014-07-11
K141334 — REUSABLE GUIDEKoelis·Product code ITX·2014-07-11
K141368 — NEUROPACE BURR HOLE COVERNeuroPace, Inc.·Product code GXR·2014-07-11
K141388 — SYSTEM CALIBRATERBeckman Coulter Ireland, Inc.·Product code JIX·2014-07-11
K141486 — MYLABSIX ULTRASOUND SYSTEMEsaote Europe B.V.·Product code IYN·2014-07-11
K141550 — INSTAFIX SHAPE MEMORY FIXATION SYSTEMOt Medical·Product code JDR·2014-07-11
K141554 — ESIE APPS SUITESiemens Medical Solutions USA, Inc.·Product code LLZ·2014-07-11
K141558 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICESurgical Specialties Corp·Product code GAM·2014-07-11
K141582 — CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTIONWelch Allyn·Product code DPS·2014-07-11
K131692 — BLOSSOM SALINE DELIVERY ASSIST DEVICEMarz Medical, Inc.·Product code LCJ·2014-07-10
K132919 — GANTRY BEAM LINEIon Beam Applications S.A.·Product code LHN·2014-07-10
K133443 — MARATHON NO STING LIQUID SKIN PROTECTANTAdvanced Medical Solutions (Plymouth), Ltd.·Product code KMF·2014-07-10
K133819 — VERADIUSPhilips Medical Systems Nederland B.V.·Product code OWB·2014-07-10
K140101 — ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARSAb Medica Sas·Product code GCJ·2014-07-10
K140626 — MELUNA CLASSIC/SPORT MENSTRUAL CUPMeluna·Product code HHE·2014-07-10
K140658 — THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODESConmed Corporation·Product code GEI·2014-07-10
K140765 — RANGE/MESA/DENALI SPINAL SYSTEMK2m, Inc.·Product code NKB·2014-07-10
K140976 — ENADEN FLOWKm Corporation·Product code EBF·2014-07-10
K141027 — 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMPImplantech Associates, Inc.·Product code FWP·2014-07-10
K134005 — MIROCAM CAPSULE ENDOSCOPE SYSTEMIntromedic Co., Ltd.·Product code NEZ·2014-07-09
K140409 — FLENTS PLASTIC EYE WASH CUPApothecary Products, Inc.·Product code LXQ·2014-07-09
K140417 — DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEMMedtronic Sofamor Danek, Inc.·Product code KWQ·2014-07-09
K140513 — MERIT SAFETY INTRODUCER NEEDLEMerit Medical Systems, Inc.·Product code DYB·2014-07-09

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