FDA 510(k) clearances — page 410

176,542 clearances on record, most recent first.

Clearances — page 410

40,901–41,000 of 176,542

K132249 — ADVIA CENTAUR FT4, ADVIA CENTAUR T4Siemens Healthcare Diagnostics, Inc.·Product code CEC·2013-09-13
K132573 — VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACINbioMerieux, Inc.·Product code LON·2013-09-13
K132578 — INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEMBoston Scientific Corp·Product code KRD·2013-09-13
K112796 — SURGICAL GOWN (EO STERILIZED)Cobes Industries Co., Ltd.·Product code FYA·2013-09-12
K124037 — JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLEJung Rim Medical Industrial Co., Ltd.·Product code FMF·2013-09-12
K130417 — AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T SAudifon-USA, Inc.·Product code KLW·2013-09-12
K130604 — UNIVERSAL PASTE STAINS AND GLAZEPrismatik Dentalcraft, Inc.·Product code EIH·2013-09-12
K130703 — VIVORTE BVFVivorte, Inc.·Product code MBP·2013-09-12
K130925 — AUTOMATIC BLOOD PRESSURE MONITORHonsun (Nantong) Co., Ltd.·Product code DXN·2013-09-12
K131578 — IPROPHY MOBILENakanishi, Inc.·Product code EKX·2013-09-12
K131802 — EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEMDepuy Spine, A Johnson & Johnson Company·Product code OSH·2013-09-12
K132137 — MULTISTIMMetron Medical Australia, Pty, Ltd.·Product code IPF·2013-09-12
K132198 — ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAICeremed , Inc.·Product code KHJ·2013-09-12
K132302 — QXLINKVieworks Co., Ltd.·Product code LLZ·2013-09-12
K132505 — ACCULIF TL AND PL CAGECoalign Innovations, Inc.·Product code MAX·2013-09-12
K130841 — SHOFU BLOCK HCShofu Dental Corporation·Product code EBF·2013-09-11
K131021 — PULSE OXIMETERNonin Medical, Inc.·Product code DQA·2013-09-11
K131111 — IHEALTH FINGERTIP PULSE OXIMETERAndon Health Co, Ltd.·Product code DQA·2013-09-11
K131208 — BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,Bausch & Lomb, Inc.·Product code LPL·2013-09-11
K131491 — KITAZATO IUI CATHETERKitazato Medical Co., Ltd.·Product code MQF·2013-09-11
K131565 — XTAG CYP2C19 KIT V3Luminex Molecular Diagnostics, Inc.·Product code NTI·2013-09-11
K123567 — FIRST RESPONSE GOLD DIGITAL PREGNANCY TESTChurch & Dwight Co., Inc.·Product code LCX·2013-09-10
K123896 — CCS-200 SPIROMETERBenson Medical Instruments Co.·Product code BZG·2013-09-10
K131043 — APEX UNIVERSAL ADHESIVEApex Dental Materials, Inc.·Product code KLE·2013-09-10
K131250 — TIGER SPINE SYSTEMCorelink, LLC·Product code NKB·2013-09-10
K132005 — RETROGRADE FEMORAL NAILAdvanced Orthopaedic Solutions, Inc.·Product code HSB·2013-09-10
K122102 — POWER FREE VINYL EXAMINATION GLOVESWang Tong Xinghua Co., Ltd.·Product code LYZ·2013-09-09
K123630 — FRESENIUS LIBERTY CYCLERFresenius Medical Care North America, Design Cente·Product code FKX·2013-09-09
K131138 — RESPIRE PINK SERIES - HERBSTRespire Medical·Product code LRK·2013-09-09
K132073 — EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULESt Jude Medical·Product code DQK·2013-09-09
K132216 — BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTIONBausch & Lomb, Incorporated·Product code LPN·2013-09-09
K132465 — BIOSIGN FLU A + B, STATUS FLU A & BPrinceton BioMeditech Corp.·Product code PSZ·2013-09-09
K121033 — VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)Ventana Medical Systems, Inc.·Product code NOT·2013-09-06
K121844 — POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVESWorldmed Manufacturing Sdn. Bhd.·Product code LYY·2013-09-06
K122235 — RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SETTeleflexmedical, Inc.·Product code JOH·2013-09-06
K130010 — PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAYNanostring Technologies·Product code NYI·2013-09-06
K130341 — STRAWBERRY, STRAWBERRY & CREAMLaser Lipo Limited·Product code OLI·2013-09-06
K130349 — FREEMIE BREAST COLLECTION SYSTEMDao Health·Product code HGX·2013-09-06
K130409 — ALIVECOR HEART MONITORAliveCor, Inc.·Product code DPS·2013-09-06
K130893 — XPERCT REL. 3Philips Medical Systems Nederland B.V.·Product code OWB·2013-09-06
K131037 — LIAISON XL HCGDiaSorin, Inc.·Product code DHA·2013-09-06
K131357 — PEAK ZUltradent Products, Inc.·Product code KLE·2013-09-06
K131389 — JUSHA-C31 MEDICAL DISPLAYNanjing Jusha Display Technology Co., Ltd.·Product code LLZ·2013-09-06
K131442 — FIRECR DENTALIMAGING SYSTEM3Disc Americas·Product code MUH·2013-09-06
K131658 — GORE SEAMGUARD REINFORCEMENTW. L. Gore & Associates, Inc.·Product code OXC·2013-09-06
K131681 — EYESEECAM VHITInteracoustics A/S·Product code GWN·2013-09-06
K131813 — QUIDEL MOLECULAR RSV + HMPV ASSAYQuidel Corp.·Product code OCC·2013-09-06
K132136 — SINGLE USE GROUNDING PADLccs Products Limited·Product code GEI·2013-09-06
K132233 — K-PACK II NEEDLE - 27G X 3/4 THIN WALLTerumo Europe N.V.·Product code FMI·2013-09-06
K132239 — COMPREHENSIVE REVERSE SHOULDER SCREWSBiomet Manufacturing Corp·Product code PHX·2013-09-06
K132324 — SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTMedos International SARL·Product code KWQ·2013-09-06
K132431 — THERMAGE CPT SYSTEMSolta Medical, Inc.·Product code GEI·2013-09-06
K123723 — SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEMSynthes·Product code GWO·2013-09-05
K123811 — STITCHKITOrigami Surgical, LLC·Product code NBY·2013-09-05
K123944 — KOSTEC MEDICAL GRADE LDC MONITORSKostec Co., Ltd.·Product code LLZ·2013-09-05
K131311 — ARIX FOOT SYSTEMJeil Medical Corporation·Product code HRS·2013-09-05
K131452 — PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300St. Jude Medical Systems AB·Product code DXO·2013-09-05
K131701 — Z5MLB, Z5MLCZ-Systems AG·Product code DZE·2013-09-05
K131764 — ACUMED WRIST SPANNING PLATEAcumed, LLC·Product code HRS·2013-09-05
K132348 — TEPHAFLEX BRAIDED SUTURETepha, Inc.·Product code NWJ·2013-09-05
K132492 — LIAISON 25 TOTAL-DDiaSorin, Inc.·Product code MRG·2013-09-05
K121924 — INTEGRA INTERSPINOUS PROCESS SYSTEMSeaspine, Inc.·Product code PEK·2013-09-04
K131044 — SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATIONDiacoustic Medical Devices (Pty) , Ltd.·Product code DQD·2013-09-04
K131064 — BIOSPACEBiospace Corporation Limited·Product code DXN·2013-09-04
K131148 — THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATHAccess Scientific, LLC·Product code DYB·2013-09-04
K131615 — POLARIS SPINAL SYSTEMBiomet Spine (Aka Ebi, LLC)·Product code OSH·2013-09-04
K131980 — SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEMZimmer Spine, Inc.·Product code NKB·2013-09-04
K132045 — ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary Kft·Product code KPQ·2013-09-04
K132610 — 5MP GRAYSCALE LCD DISPLAYShenzhen Beacon Display Technology Co., Ltd.·Product code LLZ·2013-09-04
K123907 — PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,Biomet Manufacturing Corp·Product code KRR·2013-09-03
K130028 — RESURFX 1565NM LASER MODULELumenis, Ltd.·Product code ONG·2013-09-03
K131242 — ARDIS INTERBODY SYSTEMZimmer Spine, Inc.·Product code MAX·2013-09-03
K131296 — VARILIFT-L INTERBODY FUSION DEVICEWenzel Spine, Inc.·Product code MAX·2013-09-03
K131540 — INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICEVertebral Technologies, Inc.·Product code MAX·2013-09-03
K132366 — SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSISAccel Spine·Product code KWQ·2013-09-03
K132455 — U-MOTION II PS+ CUPUnited Orthopedic Corp.·Product code LZO·2013-09-03
K123792 — HORIZON XVU (FFR)Mennen Medical , Ltd.·Product code DQX·2013-08-30
K124044 — ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTSSeven Oaks Ranch, Inc.·Product code NUC·2013-08-30
K130165 — PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0Advanced Planimetric Services, LLC·Product code FXN·2013-08-30
K130610 — SIRIUS FEMORAL STEMBiomet, Inc.·Product code JDI·2013-08-30
K130792 — LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEMC.R. Bard, Inc.·Product code FGE·2013-08-30
K130931 — EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENSJiangsu Horien Contact Lens Co., Ltd.·Product code LPL·2013-08-30
K131184 — INTEGRA LICOX PTO2 MONITORIntegra Lifesciences Corp.·Product code GWM·2013-08-30
K131241 — SWIPPhilips Medical Systems Nederland B.V.·Product code LNH·2013-08-30
K131363 — ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEMCilag GmbH International·Product code NBW·2013-08-30
K131378 — SUS (STENFILCON A) CONTACT LENSCooperVision, Inc.·Product code LPL·2013-08-30
K131430 — CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIALKuraray Noritake Dental, Inc.·Product code KLE·2013-08-30
K131455 — RESTORE MODULAR STERILIZATION TRAY SYSTEMRestore Medical Solutions, Inc.·Product code KCT·2013-08-30
K131558 — PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6Shenzhen Pango Electronic Co., Ltd.·Product code DXN·2013-08-30
K131576 — OPTIMA CT660Ge Medical Systems, LLC·Product code JAK·2013-08-30
K131784 — RANGE SPINAL SYSTEMK2m, Inc.·Product code OSH·2013-08-30
K131818 — VITAL SIGNS MONITOREdan Instruments, Inc.·Product code DQA·2013-08-30
K132146 — SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)St. shine Optical Co., Ltd.·Product code LPL·2013-08-30
K132207 — UTF STEM-REDUCED, ADDITIONAL SIZESUnited Orthopedic Corporation·Product code LPH·2013-08-30
K132281 — ReVive PV (Peripheral Vasculature) Thrombectomy DeviceCodman & Shurtleff, Inc.·Product code QEW·2013-08-30
K132359 — MRI PATIENT MONITORING SYSTEMInvivo Corporation·Product code MWI·2013-08-30
K132374 — BAYLIS MEDICAL RF PERFORATION PROBE V2.0Baylis Medical Company, Inc.·Product code GEI·2013-08-30
K122885 — MEDISIZE GOLD HEATER AND BOOSTER T-PIECEMedisize BV·Product code BTT·2013-08-29
K123540 — SYNGO CT PULMO 3DSiemens Medical Systems, Inc.·Product code JAK·2013-08-29
K123947 — ARCHITECT IVANCOMYCINBiokit, S.A.·Product code LEH·2013-08-29

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