FDA 510(k) clearances — page 418

176,542 clearances on record, most recent first.

Clearances — page 418

41,701–41,800 of 176,542

K131112 — LIMACORPORATE SMR CTA HUMERAL HEADSLima Corporate S.P.A.·Product code KWS·2013-06-07
K131115 — ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRENds Surgical Imaging·Product code GCJ·2013-06-07
K131217 — S TEST REAGENT CARTRIDGE TOTAL BILIRUBINHitachi Chemical Diagnostics, Inc.·Product code CIG·2013-06-07
K131300 — THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETERAccess Scientific, LLC·Product code DYB·2013-06-07
K120931 — CRITICAL CARE VENTILATOROricare, Inc.·Product code CBK·2013-06-06
K121436 — DAS MEDICAL EQUIPMENT DRAPESDas Medical, LLC·Product code KKX·2013-06-06
K121642 — WIZARD 230 NASAL PILOW MASKApex Medical Corp.·Product code BZD·2013-06-06
K121902 — NATRATONEOrelle Corporation, Ltd.·Product code HIR·2013-06-06
K123394 — CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSINGCoreleader Biotech Co., Ltd.·Product code FRO·2013-06-06
K123481 — AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVEConvatec, Inc.·Product code FRO·2013-06-06
K130149 — U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USEUnited Orthopedic Corporation·Product code LPH·2013-06-06
K130645 — AQUILION PRIME, V5.00Toshibamedical Systems Corporation·Product code JAK·2013-06-06
K130739 — ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMSSiemens Medical Solutions USA, Inc.·Product code IYN·2013-06-06
K131103 — XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIRSorin Group Italia S.R.L.·Product code DTN·2013-06-06
K131329 — VECTOR PTA BALLOON DILATATION CATHETERR4 Vascular, Inc.·Product code LIT·2013-06-06
K131346 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITORMicrolife Intellectual Property GmbH·Product code DXN·2013-06-06
K120954 — NOBELPROCERA PEEK ABUTMENTSNobel Biocare AB·Product code NHA·2013-06-05
K122020 — PHOTON PHOTON PLUSZolar Technology & Mfg Co., Inc.·Product code GEX·2013-06-05
K123101 — TRC-50DX RETINAL CAMERATopcon Medical Systems, Inc.·Product code HKI·2013-06-05
K123423 — ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KITMeridian Bioscience, Inc.·Product code OZX·2013-06-05
K123518 — ABBOTT CARBAMAZEPINE ASSAYMicrogenics Corporation·Product code KLT·2013-06-05
K123843 — NEUROEPG SYSTEMStrohl Medical Technologies·Product code GWF·2013-06-05
K130328 — F&P SIMPLUS FULL FACE MASKFisher & Paykel Healthcare Limited·Product code BZD·2013-06-05
K130382 — HEARTSTRING III PROXIMAL SEAL SYSTEMBoston Scientific Corporation·Product code DXC·2013-06-05
K130427 — PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEMPioneer Surgical Technology, Inc.·Product code KWQ·2013-06-05
K130598 — INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBERInspirx, Inc.·Product code NVP·2013-06-05
K130599 — WART FREEZEKoninklijke Utermohlen NV·Product code GEH·2013-06-05
K130773 — TEMPUS PRO PATIENT MONITORRemote Diagnostic Technologies , Ltd.·Product code MWI·2013-06-05
K131321 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek USA·Product code OSH·2013-06-05
K122365 — ULTRACHECK CURVE BLOOD PRESSURE CUFFSStatcorp Medical·Product code OED·2013-06-04
K122791 — LYOPLANT ONLAYAesculap, Inc.·Product code GXQ·2013-06-04
K122979 — VIDAS LYME IGMBiomerieux S.A.·Product code LSR·2013-06-04
K124012 — INFILL OBLIQUE TLIF DEVICEPinnacle Spine Group, LLC·Product code MAX·2013-06-04
K130290 — MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDEIntel-Ge Care Innovations, LLC·Product code DRG·2013-06-04
K130640 — ATLANTIS ANTERIOR CERVICAL PLATE SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code KWQ·2013-06-04
K122473 — TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2Hill-Rom·Product code IOQ·2013-06-03
K122965 — HUMAN CAERULOPLASMIN KITThe Binding Site Group , Ltd.·Product code DDB·2013-06-03
K123653 — SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)Bisco, Inc.·Product code LBH·2013-06-03
K123885 — OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOROsteomed LP·Product code PBJ·2013-06-03
K124046 — VALVED TEARAWAY INTRODUCER GENERATION IIMedical Components, Inc.·Product code DYB·2013-06-03
K130507 — FOOTPRINT MEDICAL POLYURETHANE PICC CATHETERFootprint Medical, Inc.·Product code LJS·2013-06-03
K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2Cliniqa Corporation·Product code GGN·2013-05-31
K122700 — PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIESProsben, Inc.·Product code LRX·2013-05-31
K123380 — STRIDE UNICONDYLAR KNEEBlue Belt Technologies, Inc.·Product code HSX·2013-05-31
K123823 — INTERLIGAngelus Industria DE Productos Odontologicos·Product code EBF·2013-05-31
K130129 — UNIVERS REVERS SHOULDER PROSTHESIS SYSTEMArthrex, Inc.·Product code KWS·2013-05-31
K130267 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEMSpineart·Product code MNH·2013-05-31
K130277 — SINGLE ENERGY (SE) FEMUR EXAMSHologic, Inc.·Product code KGI·2013-05-31
K130293 — ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETERCook, Inc.·Product code LIT·2013-05-31
K130319 — MEDLINE CANNULATED SCREWMedline Industries, Inc.·Product code HWC·2013-05-31
K130332 — VITROS CHEMISTRY PRODUCTS TRIG SLIDESOrtho-Clinical Diagnostics, Inc.·Product code CDT·2013-05-31
K130338 — IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSISImpediMed Limited·Product code OBH·2013-05-31
K130412 — OSTEOMED EXTREMIFUSE SYSTEMOsteomed·Product code HWC·2013-05-31
K130432 — PHT-6500, PHT-60CFOVATECH Co., Ltd.·Product code OAS·2013-05-31
K130474 — SURGISEAL TOPICAL SKIN ADHESIVEAdhezion Biomedical, LLC·Product code MPN·2013-05-31
K130498 — OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBacterin International, Inc.·Product code MBP·2013-05-31
K130547 — ENDOFORM RECONSTRUCTIVE TEMPLATEMesynthe, Ltd.·Product code FTM·2013-05-31
K130954 — ARS SCREW; SLANT SCREWAdvanced Interventional Technology, LLC·Product code HWC·2013-05-31
K131132 — PELVIS II IMPLANT SYSTEMStryker Trauma AG·Product code HRS·2013-05-31
K131136 — GLUCOSE METER-CHECK SOLUTION FOR TAIDOCBionostics, Inc.·Product code JJX·2013-05-31
K131232 — WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)Guangzhou Wondfo Biotech Co., Ltd.·Product code DJR·2013-05-31
K131324 — MAXTORQUE SCREW SYSTEMOrthohelix Surgical Designs, Inc.·Product code HWC·2013-05-31
K120901 — HUMAN IGA CSF KIT FOR USE ON SPAPLUSThe Binding Site Group , Ltd.·Product code CFN·2013-05-30
K122663 — ORAMOISTQuantum, Inc.·Product code LFD·2013-05-30
K123202 — PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENSCooperVision, Inc.·Product code LPL·2013-05-30
K123491 — BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENTBiodenta Swiss AG·Product code NHA·2013-05-30
K123844 — CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TESTChemtron Biotech, Inc.·Product code JHI·2013-05-30
K130287 — MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODERhythmlink International, LLC·Product code GXY·2013-05-30
K130311 — TRANSTEK BODY FAT ANALYZERGuangdong Transtek Medical Electronics Co., Ltd.·Product code MNW·2013-05-30
K130532 — IDRIVE ULTRA STERILIZATION TRAYCovidien, Formerly US Surgical A Divison of Tyco H·Product code KCT·2013-05-30
K130699 — ALEUTIAN SPINAL SYSTEMK2m, Inc.·Product code MAX·2013-05-30
K130869 — TAKE 1 ADVANCESybron Dental Specialties·Product code ELW·2013-05-30
K131027 — MEMORY PUMP MODEL Y4947Tomy International·Product code HGX·2013-05-30
K131199 — ULTRAVERSE RX PTA BALLOON DILATATION CATHETERBard Peripheral Vascular, Inc.·Product code LIT·2013-05-30
K131216 — RAMPART OSpineology, Inc.·Product code MAX·2013-05-30
K131404 — FLASH AR PENTA / FLASH AR PENTA QUICK3M Deutschland GmbH·Product code ELW·2013-05-30
K123041 — VASOSTAT HEMOSTASIS DEVICEForge Medical, Inc.·Product code DXC·2013-05-29
K124056 — FREND PSA PLUS (REAGENT CARTRIDGE)Nanoentek, Inc.·Product code LTJ·2013-05-29
K130170 — EXSPIRON 1XIRespiratory Motion, Inc.·Product code BZK·2013-05-29
K130278 — MR PERMEABILITYPhilips Medical Systems Nederland B.V.·Product code LLZ·2013-05-29
K130288 — STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICECardiac Insight, Inc.·Product code DSH·2013-05-29
K130297 — SCANORA 3DXPalodex Group OY·Product code OAS·2013-05-29
K130354 — MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)Entrigue Surgical, Inc.·Product code LYA·2013-05-29
K130411 — 740 SELECTCas Medical Systems, Inc.·Product code MWI·2013-05-29
K131045 — ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARECardiac Designs, LLC·Product code DQK·2013-05-29
K131121 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITORHealth & Life Co., Ltd.·Product code DXN·2013-05-29
K131225 — ADROIT GUIDING CATHETERCordis Corp., A Johnson & Johnson Co.·Product code DQY·2013-05-29
K131295 — NIO COLOR 3MP LEDBarco N.V.·Product code LLZ·2013-05-29
K131392 — ETIAM PACS COMPONENTSEtiam S.A.S.U.·Product code LLZ·2013-05-29
K123034 — VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMEDUnilene Sac·Product code GAR·2013-05-28
K123801 — FINGER PULSE OXIMETERShenzhen Kingyield Technology Co., Ltd.·Product code DQA·2013-05-28
K130343 — CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADSCorin USA·Product code LZO·2013-05-28
K121065 — POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICEPolymed Therapeutics, Inc.·Product code DKZ·2013-05-24
K121898 — STAY FRESH SKIN FOLD MANAGEMENT TEXTILEQuick-Med Technologies, Inc.·Product code FRL·2013-05-24
K122639 — SYNTHES SYNCAGE EVOLUTION SPACERSynthes (USA) Products, LLC·Product code MAX·2013-05-24
K122801 — PROVIDENCE CERVICAL CAGEProvidence Medical Technology, Inc.·Product code ODP·2013-05-24
K123569 — ANTEGRADE FEMORAL NAILAdvanced Orthopaedic Solutions, Inc.·Product code HSB·2013-05-24
K123619 — INTRABLOCK BIOBALL HIP SYSTEM (IBS)Merete Medical GmbH·Product code LZO·2013-05-24
K123692 — PIPELINE KNEE SYSTEMPipeline Orthopedics·Product code JWH·2013-05-24
K123746 — AMES THERAPY DEVICEAmes Technology, Inc.·Product code IKK·2013-05-24

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