FDA 510(k) clearances — page 386

176,542 clearances on record, most recent first.

Clearances — page 386

38,501–38,600 of 176,542

K140134 — ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECEStarboard Medical, LLC·Product code BZT·2014-06-16
K140215 — ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARDCo-Innovation Biotech Co., Ltd.·Product code DIS·2014-06-16
K140317 — EMBRYOGENOrigio A/S·Product code MQL·2014-06-16
K140443 — ARIETTA 60/ARIETTAS60/ARIETTAV60Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical·Product code IYN·2014-06-16
K140519 — RECOVERY PUMP 737RMego Afek AC , Ltd.·Product code IRP·2014-06-16
K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVELeomed, LLC·Product code KNY·2014-06-16
K140570 — CHAIRSIDE ATTACHMENT PROCESSING MATERIALZest Anchors, LLC·Product code EBI·2014-06-16
K140623 — NXSTAGE EXPRESS FLUID WARMERNxstage Medical, Inc.·Product code FLA·2014-06-16
K140708 — VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATORSTERIS Corporation·Product code FRC·2014-06-16
K140713 — PLANMECA ROMEXISPlanmeca Oy·Product code LLZ·2014-06-16
K140760 — BONASTENT BILIARYEndochoice, Inc.·Product code FGE·2014-06-16
K140992 — ARTHROCARE NASASTENT CMC NASAL DRESSINGArthroCare Corporation·Product code LYA·2014-06-16
K132566 — REPROCESSED HARMONIC SHEARSterilmed, Inc.·Product code NLQ·2014-06-14
K122807 — DENTAL IMPLANT SYSTEMHager& Meisinger GmbH·Product code DZE·2014-06-13
K131080 — PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITEReimers and Janssen GmbH·Product code ILY·2014-06-13
K132003 — WINX SLEEP THERAPY SYSTEMApnicure, Inc.·Product code OZR·2014-06-13
K132524 — CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATIONPhilips Medical Systems·Product code JAK·2014-06-13
K132816 — ONCENTRA BRACHYNucletron B.V.·Product code MUJ·2014-06-13
K132978 — IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TESTSequenom, Inc.·Product code PHJ·2014-06-13
K133098 — SENYINT PACSDalian Senyint Digital Medical System Co., Ltd.·Product code LLZ·2014-06-13
K133553 — KALAREToshiba America Medical Systems, In.C·Product code JAA·2014-06-13
K133661 — CHAIR SENSING UNIT FOR EARLYSENSE SYSTEMEarlysense, Ltd.·Product code BZQ·2014-06-13
K133884 — BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MMBiodenta Swiss AG·Product code DZE·2014-06-13
K140075 — U2 FEMORAL COMPONENT, CR, POROUS COATEDUnited Orthopedic Corp.·Product code MBH·2014-06-13
K140312 — EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEMEdwards Lifesciences, LLC·Product code DXN·2014-06-13
K140430 — 740 SELECTCas Medical Systems, Inc.·Product code MWI·2014-06-13
K140437 — SU-POR SURGICAL IMPLANTPoriferous, LLC·Product code KKY·2014-06-13
K140462 — MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)Synthes (USA) Products, LLC·Product code GWO·2014-06-13
K140666 — MR ELASTOGRAPHYPhilips Medical Systems Nederland B.V.·Product code LNH·2014-06-13
K140759 — BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERALMedos International SARL·Product code MAX·2014-06-13
K140799 — CELERITY SYSYEMMedcomp (Medical Components, Inc.)·Product code LJS·2014-06-13
K140960 — PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMHologic, Inc.·Product code LLZ·2014-06-13
K141055 — LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)Lin-Zhi International, Inc.·Product code DJG·2014-06-13
K141383 — ACUMED HAND FRACTURE SYSTEMAcumed, LLC·Product code HRS·2014-06-13
K141520 — ALERE I INFLUENZA A & BAlere Scarborough, Inc D/B/A Binax, Inc.·Product code OCC·2014-06-13
K132375 — GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAGGenicon·Product code GCJ·2014-06-12
K133280 — TERUMO SURFLO I.V. CATHETERTerumo (Philippines) Corporation·Product code FOZ·2014-06-12
K140239 — JIAWANGJiawang Glove Co., Ltd.·Product code LYZ·2014-06-12
K140240 — ZHAOFENGZhaofeng Glove Co., Ltd.·Product code LYZ·2014-06-12
K140242 — FEIYUEFeiyue Glove Co., Ltd.·Product code LYZ·2014-06-12
K140314 — WARTIE WART REMOVERYonmedical BV·Product code GEH·2014-06-12
K140322 — WHITE VINYL EXAM GLOVES POWDER FREEShandong Dawei Medical Products Co., Ltd.·Product code LYZ·2014-06-12
K140361 — META-C CERVICAL PLATEMedacta International·Product code KWQ·2014-06-12
K140695 — COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIREMedtronic, Inc.·Product code DQX·2014-06-12
K140730 — VIAL2BAG DIRECT CONNECTMedimop Medical Projects, Ltd.·Product code LHI·2014-06-12
K141233 — AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACEMedtronic, Inc.·Product code DTN·2014-06-12
K141306 — TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITETeva Medical Ltd., Migada Plant·Product code FPA·2014-06-12
K141360 — TRIPLEPLAY PROWildcat Medical, Inc.·Product code JOW·2014-06-12
K141381 — DURADIAGNOSTPhilips Healthcare (Suzhou) Co., Ltd.·Product code KPR·2014-06-12
K131858 — DIGITAL ELECTROCARDIOGRAPHGuangdong Biolight Meditech Co., Ltd.·Product code DPS·2014-06-11
K132954 — JO PREMIUM PERSONAL LUBRICANTUnited Consortium·Product code NUC·2014-06-11
K133132 — OPTICAL BIOMETER AL-SCANNidek Co., Ltd.·Product code HJO·2014-06-11
K133403 — FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENSFirestone Optics, Inc.·Product code LPL·2014-06-11
K134022 — BASE ITSpident Co., Ltd.·Product code EJK·2014-06-11
K140425 — CONTRAST MODULATION SYSTEMOsprey Medical, Inc.·Product code DXT·2014-06-11
K140651 — CELESTEION, PCA-9000A/2Toshibamedical Systems Corporation·Product code KPS·2014-06-11
K140662 — FLEX ENDOSCOPIC INSTRUMENTSDesign Standards Corp.·Product code GCJ·2014-06-11
K140854 — INTRA-OPERATIVE ULTRASOUND TRANSDUCERHitachi Aloka Medical, Ltd.·Product code ITX·2014-06-11
K140955 — MTA2.1 MATERIALAvalon Biomed, Inc.·Product code KIF·2014-06-11
K140996 — MAMMIGeneral Equipment For Medical Imaging (Oncovision-·Product code KPS·2014-06-11
K141250 — FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEMKARL STORZ Endoscopy-America, Inc.·Product code FGB·2014-06-11
K132920 — SPIROX INEX DEVICESpirox, Inc.·Product code NHB·2014-06-10
K133297 — QUADROSTARPROGREEN, QUADROSTARPROYELLOWAsclepion Laser Technologies GmbH·Product code GEX·2014-06-10
K133494 — CHESAPEAKE SPINAL SYSTEMK2m, Inc.·Product code OVD·2014-06-10
K133770 — A.I.M. KNOTLESS MENISCAL REPAIR DEVICEAnchor Innovation Medical (A.I.M.)·Product code GAT·2014-06-10
K134021 — ESTEMP IMPLANT, ESTEMP CLEARSpident Co., Ltd.·Product code EMA·2014-06-10
K140138 — HEARTNAVIGATOR RELEASE 2.0Philips Medical Systems Nederland B.V.·Product code OWB·2014-06-10
K140331 — ORTHALIGN PLUS SYSTEMOrthalign, Inc.·Product code OLO·2014-06-10
K140374 — MASTERGRAFT PUTTYMedtronic Sofamor Danek USA, Inc.·Product code LYC·2014-06-10
K140521 — TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCHArthroCare Corporation·Product code GEI·2014-06-10
K140642 — PCD 737AMego Afek AC , Ltd.·Product code JOW·2014-06-10
K140675 — EMERGE EXTERNAL FIXATION SYSTEMEmerge Medical, Inc.·Product code KTT·2014-06-10
K140967 — FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISKInsightra Medical·Product code FTL·2014-06-10
K140975 — MASTERSL FEMORAL STEMLima Corporate S.P.A.·Product code LZO·2014-06-10
K140985 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATESThermo Fisher Scientific·Product code JWY·2014-06-10
K141019 — AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM; REFURBISHEDFenwal, Inc.·Product code LKN·2014-06-10
K141259 — GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEKDepuy Mitek, A Johnson & Johnson Company·Product code MAI·2014-06-10
K131323 — ECLERIS SINUSCOPEEcleris USA·Product code EOB·2014-06-09
K132901 — AIRSOFT F15Resmed, Ltd.·Product code BZD·2014-06-09
K133012 — SENTIEROPath Medical GmbH·Product code EWO·2014-06-09
K140357 — OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEMOrthopaedic Implant Company·Product code HRS·2014-06-09
K140539 — AERO BLUE PERFORMANCE SURGICAL GOWNKimberly-Clark Corporation·Product code FYA·2014-06-09
K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIESConvida Healthcare & Systems Corporation·Product code FSY·2014-06-09
K141252 — GUARDIAN URETHRAL SHEATHSolace Therapeutics·Product code KNY·2014-06-09
DEN120015 — EEVA 2.0Auxogyn, Inc.·Product code PBH·2014-06-06
K131762 — HANDHELD MONITORGuangdong Biolight Meditech Co., Ltd.·Product code MWI·2014-06-06
K132205 — ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEMInova Labs, Inc.·Product code CAW·2014-06-06
K132415 — RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBETeleflexmedical, Inc.·Product code BTR·2014-06-06
K132960 — BIOMONITORBiotronik, Inc.·Product code MXD·2014-06-06
K133774 — ATOVENBio-Med USA, Inc.·Product code GEX·2014-06-06
K140112 — CA 125 II CALSET IIRoche Diagnostics·Product code JIT·2014-06-06
K140353 — STARBAND AND STARLIGHTOrthomerica Products, Inc.·Product code MVA·2014-06-06
K140546 — HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TESTHealgen Scientific,, LLC·Product code LDJ·2014-06-06
K140871 — AXERA 2 ACCESS SYSTEMArstasis, Inc.·Product code DYB·2014-06-06
K140972 — UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACINGMedtronic, Inc.·Product code LDF·2014-06-06
K141050 — ENSITE VELOCITY SYSTEMSt Jude Medical·Product code DQK·2014-06-06
K141060 — CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENTOn-X Life Technologies, Inc.·Product code PAW·2014-06-06
K141185 — V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEMBoston Scientific Corp·Product code DQK·2014-06-06
K141192 — DR 400Agfa Healthcare N.V.·Product code MQB·2014-06-06
K131567 — ALADDINVisia Imaging S.R.L.·Product code HJO·2014-06-05

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