FDA 510(k) clearances — page 399

176,542 clearances on record, most recent first.

Clearances — page 399

39,801–39,900 of 176,542

K133301 — ZOE FLUID STATUS MONITORNoninvasive Medical Technologies, Inc.·Product code DSB·2014-01-22
K133414 — REPROCESSED CLOSURE SYSTEMSterilmed, Inc.·Product code NLM·2014-01-22
K133907 — VSP SYSTEMMedical Modeling, Inc.·Product code DZJ·2014-01-22
K133938 — ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGYCovidien·Product code GDW·2014-01-22
K133950 — ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)Bioretec, Ltd.·Product code HTY·2014-01-22
K133960 — LYPOCHEK SPECIALTY IMMUNOASSAY CONTROLBio-Rad Laboratories·Product code JJY·2014-01-22
K132125 — A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEMA.B. Dental Devices , Ltd.·Product code DZE·2014-01-21
K132499 — ICRCO CLARITY VIEWERIcrco, Inc.·Product code LLZ·2014-01-21
K132764 — MOTION WATCH AND PRO-DIARYCamntech, Ltd.·Product code LEL·2014-01-21
DEN130018 — CYTOSCAN(R) DXAffymetrix, Inc.·Product code PFX·2014-01-17
K123517 — GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEMSd Biosensor·Product code NBW·2014-01-17
K130614 — BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERSLaura Cattabriga·Product code HRS·2014-01-17
K131168 — IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAYImmunalysis Corporation·Product code DJG·2014-01-17
K131245 — OREGON SCINTIFICIdt Technology Limited·Product code DXN·2014-01-17
K131623 — SMARTDOP XTKoven Technology, Inc.·Product code JOP·2014-01-17
K132065 — INJECTION NEEDLEEndochoice, Inc.·Product code FBK·2014-01-17
K132410 — DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 WGe Medical Systems, LLC·Product code JAK·2014-01-17
K132668 — IOB DISPOSABLE SPECULUMIob Medical, Inc.·Product code HIB·2014-01-17
K132682 — PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CAAtheromed, Inc.·Product code MCW·2014-01-17
K132890 — SUPRAPUBIC CATHETER AND INTRODUCER SETMediplus , Ltd.·Product code KOB·2014-01-17
K132921 — GALAXY PLUSMedien International Co, Ltd.·Product code MQB·2014-01-17
K132931 — APOLLO SYSTEMPenumbra, Inc.·Product code GWG·2014-01-17
K133197 — FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODEFujirebio Diagnostics,Inc.·Product code JJX·2014-01-17
K133228 — ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEMIconacy Orthopedic Implants, LLC·Product code LPH·2014-01-17
K133277 — XARIO 100Toshibamedical Systems Corporation·Product code IYN·2014-01-17
K133375 — BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCARBanyan Medical, LLC·Product code GCJ·2014-01-17
K133424 — SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16Siemens Medical Solutions USA, Inc.·Product code JAK·2014-01-17
K133464 — MODIFIED TREVO PROVUE RETRIEVERConcentric Medical, Inc.·Product code NRY·2014-01-17
K133833 — NUVIS DIAGNOSTIC ULTRASOUND SYSTEMPhilips Ultrasound, Inc.·Product code IYN·2014-01-17
K133869 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KITCenter For Disease Control and Prevention (Cdc)·Product code OZE·2014-01-17
K133875 — THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATAOrtho Kinematics, Inc.·Product code LLZ·2014-01-17
K130732 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Aide Plastic Co., Ltd.·Product code LYZ·2014-01-16
K130945 — CALPRESTEurospital S.P.A.·Product code NXO·2014-01-16
K131151 — ENDOCENTERSatelec - Acteon Group·Product code ELC·2014-01-16
K131799 — QUICKNITMicrocopy, Div. of Neo-Flo, Inc.·Product code MVL·2014-01-16
K131857 — Q-SWITCHED ND:YAG LASERBeijing Honkon Technologies Co., Ltd.·Product code GEX·2014-01-16
K132363 — DOLPHIX EXTERNAL FIXATION SYSTEMCitieffe S.R.L.·Product code KTT·2014-01-16
K132528 — E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIESGE Healthcare Finland Oy·Product code DXG·2014-01-16
K132894 — OPTIO-C ANTERIOR CERVICAL SYSTEMZimmer Spine, Inc.·Product code OVE·2014-01-16
K133164 — DYNESYS TOP-LOADING SPINAL SYSTEMZimmer Spine, Inc.·Product code NQP·2014-01-16
K133250 — STARLIGHTOrthomerica Products, Inc.·Product code OAN·2014-01-16
K133379 — HEM-7311Omron Healthcare, Inc.·Product code DXN·2014-01-16
K133698 — SYNAPSE SYSTEMSynthes USA Products, LLC·Product code KWP·2014-01-16
K133727 — Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTUArthroCare Corporation·Product code MBI·2014-01-16
K133856 — POWERGLIDE MIDLINE CATHETERC.R. Bard, Inc.·Product code FOZ·2014-01-16
K131110 — ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARDCo-Innovation Biotech Co., Ltd.·Product code DKZ·2014-01-15
K131113 — BIOPHOTAS CELLUMABiophotas, Inc.·Product code ILY·2014-01-15
K131864 — U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENTUnited Orthopedic Corporation·Product code JWH·2014-01-15
K132844 — STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGESStraumann USA, LLC·Product code NHA·2014-01-15
K133106 — COMPUTED RADIOGRAPHY SCANNER3Disc Americas·Product code MQB·2014-01-15
K133120 — COMPUTED RADIOGRAPHY SCANNER3Disc Americas·Product code MQB·2014-01-15
K133473 — ILUMINAGE SKIN SMOOTHING LASERCynosure, Inc.·Product code OHS·2014-01-15
K123758 — TASMIN RSignus Medizintechnik GmbH·Product code MQP·2014-01-14
K130036 — COSENSE CO MONITORCapnia, Inc.·Product code CCJ·2014-01-14
K130692 — M2 WRIST 2 MRI SYSTEMAspect Imaging, Ltd.·Product code LNH·2014-01-14
K130735 — SYNTHETIC ABSORBABLE SUTUREFoosin Medical Supplies Inc., Ltd.·Product code GAM·2014-01-14
K130737 — SYNTHETIC ABSORBABLE SUTUREFoosin Medical Supplies Inc., Ltd.·Product code GAM·2014-01-14
K132739 — IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIALSiemens Healthcare Diagnostics, Inc.·Product code JJX·2014-01-14
K132984 — SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL SIvoclar Vivadent, Inc.·Product code ELM·2014-01-14
K133369 — TIGER SPINE SYSTEMCorelink, LLC·Product code NKB·2014-01-14
K133499 — SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEASuzhou Beinuo Medical Equipment Co. , Ltd.·Product code GDW·2014-01-14
K130552 — CT PULMONARY ANALYSISQi Imaging, LLC·Product code JAK·2014-01-13
K130674 — ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBEXeridiem Medical Devices·Product code KNT·2014-01-13
K130828 — K SERIES CPAP SYSTEMSCurative Medical, Inc.·Product code BZD·2014-01-13
K131410 — CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),Southmedic, Inc.·Product code CCK·2014-01-13
K132606 — S9 CRONULLA FOR HERResmed, Ltd.·Product code BZD·2014-01-13
K132641 — MODIFIED TREVO PROVUE RETRIEVERConcentric Medical, Inc.·Product code NRY·2014-01-13
K132669 — PROXIFAST ABSORBABLE STAPLESurgimatix, Inc.·Product code GDW·2014-01-13
K133021 — MIXING SYRINGE SYSTEMZimmer Knee Creations, Inc.·Product code FMF·2014-01-13
K133063 — SANTIS PEDICLE SCREW SYSTEMLanterna Medical Technologies·Product code NKB·2014-01-13
K133066 — SPINESELECT POLYSCREW PEDICLE SCREW SYSTEMSpineselect, LLC·Product code NKB·2014-01-13
K133407 — GEM PREMIER 4000Instrumentation Laboratory CO·Product code CHL·2014-01-13
K133684 — ULTRABLOXBloxr Corporation·Product code PDK·2014-01-13
K130087 — PANPAC WORD/BARTHOLIN CATHETERPanpac Medical Corporation·Product code KNA·2014-01-10
K130168 — CL10009 IR LASERCurae'Lase, Inc.·Product code ILY·2014-01-10
K130235 — SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTYHans Biomed Corp.·Product code NUN·2014-01-10
K130662 — ET PROSTHETIC SYSTEMOsstem Implant Co., Ltd.·Product code NHA·2014-01-10
K132071 — BIOACTIVE BONE GRAFT PUTTYBiostructures, LLC·Product code MQV·2014-01-10
K132076 — REAGENT, RUSSEL VIPER VENOM - LA CONFIRMDsrv, Inc.·Product code GIR·2014-01-10
K132130 — REAGENT, RUSSEL VIPER VENOM - LA SCREENDsrv, Inc.·Product code GIR·2014-01-10
K132210 — FUJIFILM 600 SERIES ENDOSCOPESFujifilm Medical Systems U.S.A, Inc.·Product code FDF·2014-01-10
K132335 — ULTRASOUND SCANNER FLEX FOCUS 1202B-K Medical Aps·Product code IYN·2014-01-10
K132346 — ULTRASOUND SCANNER PRO FOCUS 2202B-K Medical Aps·Product code IYO·2014-01-10
K132403 — ANNEXTM ADJACENT LEVEL SYSTEMSpine Wave, Inc.·Product code MNH·2014-01-10
K132660 — NERVE CUFFCook Biotech Incorporated·Product code JXI·2014-01-10
K132731 — DIGIFIX EXTERNAL FIXATION SYSTEMVirak Orthopedic Research, LLC·Product code JEC·2014-01-10
K133191 — PROBEAM PROTON THERAPY SYSTEMVarian Medical Systems·Product code LHN·2014-01-10
K133302 — FLEXMAP 3DLuminex Corp.·Product code NSU·2014-01-10
K133310 — AXIUM DETACHABLE COIL SYSTEMMicro Therapeutics, Inc. d/b/a ev3 Neurovascular·Product code HCG·2014-01-10
K133604 — ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTSThe Anspach Effort, Inc.·Product code HBC·2014-01-10
K121235 — LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEMStryker·Product code JEY·2014-01-09
K122982 — CRYOLOCKBiotech, Inc.·Product code MQK·2014-01-09
K123986 — ACTIM PROMAlere Scarborough, Inc.·Product code OAM·2014-01-09
K130851 — CASCADE HEMODIALYSIS/APHERESIS CATHETERHealth Line International Corporation·Product code MSD·2014-01-09
K130888 — SONOPULSE/ SONOPULSE IIIIbramed- Industria Brazileria DE Equipamentos Medi·Product code IMI·2014-01-09
K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENTRandox Laboratories, Ltd.·Product code JJE·2014-01-09
K131958 — BAUSCH & LOMB INJECTOR SYSTEMBausch & Lomb·Product code MSS·2014-01-09
K132729 — ISO-GARD MASKTeleflexmedical, Inc.·Product code CBN·2014-01-09
K132834 — FASTEP S10 HCG SERUM/URINE COMBO TESTPolymed Therapeutics, Inc.·Product code JHI·2014-01-09
K133244 — TAMPAX M PLASTIC TAMPONS, UNSCENTEDThe Procter & Gamble Company·Product code HEB·2014-01-09

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