FDA 510(k) clearances — page 376

176,542 clearances on record, most recent first.

Clearances — page 376

37,501–37,600 of 176,542

K131925 — HS NOTAH.S. Hospital Services S.P.A.·Product code FCG·2014-10-10
K133441 — ONESTEP CPR II MULTI-FUNCTION ELECTRODEBio-Detek, Inc.·Product code MKJ·2014-10-10
K140120 — EPIC 10Biolase, Inc.·Product code GEX·2014-10-10
K140463 — INTEGRA EXTERNAL FIXATION SYSTEMAscension Orthopedic·Product code KTT·2014-10-10
K140619 — MECA XPRESSFISHAdvandx, Inc.·Product code MYI·2014-10-10
K140938 — OSTOM-I ALERT11 Health and Technologies, LLC·Product code EXB·2014-10-10
K141106 — FRONTIER DEVICES FUSIO SCREW FUZE SYSTEMFolsom Metal Products, Inc. Dba Frontier Devices·Product code OUR·2014-10-10
K141399 — FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEMStimwave Technologies Incorporated·Product code GZB·2014-10-10
K141869 — QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KITHemedex Incorporated·Product code GWM·2014-10-10
K142014 — SOFIA DISTAL ACCESS CATHETERMicroVention, Inc.·Product code DQY·2014-10-10
K142033 — VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)Nanospere,Inc.·Product code PCH·2014-10-10
K142037 — QUANTRAHologic, Inc.·Product code LLZ·2014-10-10
K142160 — LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEMGE Healthcare·Product code IYN·2014-10-10
K142323 — Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel , Ltd.·Product code IYN·2014-10-10
K142614 — AngioDynamics VenaCure EVLT Tre Sheath and VenaCure EVLT NeverTouch Procedure KitsAngioDynamics, Inc.·Product code GEX·2014-10-10
K142628 — Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.·Product code IYN·2014-10-10
K132592 — FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SETCook, Inc.·Product code DYB·2014-10-09
K133990 — IEVA REHABILITATIVE POSITIONAL DEVICERemendium Labs, LLC·Product code HIR·2014-10-09
K140319 — COROENT TI-C SYSTEMNuvasive, Inc.·Product code MAX·2014-10-09
K140805 — ITCLAMP 50Innovative Trauma Care, Inc.·Product code DXC·2014-10-09
K141416 — BLOOD PRESSURE MONITORShenzhen Pump Medical System Co., Ltd.·Product code DXN·2014-10-09
K141659 — PRISM ZIRCONIA, ST-98A & D Dental Innovations·Product code EIH·2014-10-09
K141791 — BIOMET FUSION SYSTEMBiomet Spine·Product code OVD·2014-10-09
K141927 — LYRA PARAINFLUENZA VIRUS ASSAYQuidel Corporation·Product code OOU·2014-10-09
K141931 — LYRA ADENOVIRUS ASSAYQuidel Corporation·Product code OCC·2014-10-09
K141972 — KLASSIC HD ACETABULAR INSERT WITH E-LINK POLYTotal Joint Orthopedics, Inc.·Product code OQG·2014-10-09
K142396 — Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette TestsChemtron Biotech, Inc.·Product code DJG·2014-10-09
K131487 — FLUOR PROTECTOR SIvoclar Vivadent, AG·Product code LBH·2014-10-08
K133245 — GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEMGenesys Spine·Product code KWQ·2014-10-08
K140249 — LONG PULSE ND: YAG LASER SYSTEMAdvanced Technology Laser Co., Ltd.·Product code GEX·2014-10-08
K141201 — A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITORA & D Co., Ltd.·Product code DXN·2014-10-08
K141326 — NEEDLE VIEW CH SCOPE KITSBiovision Technologies, LLC·Product code HRX·2014-10-08
K141378 — IDC INTERLOCKING DETACHABLE COILBoston Scientific Corporation·Product code KRD·2014-10-08
K141456 — THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELLFiagon GmbH·Product code PGW·2014-10-08
K141855 — CLARITYElekta , Ltd.·Product code IYE·2014-10-08
K142198 — BNX Fine Needle Aspiration SystemCovidien, LLC·Product code NEU·2014-10-08
K142515 — MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM SkyraSiemens Medical Solutions USA, Inc.·Product code LNH·2014-10-08
K133040 — LED CURING LIGHTMonitex Industrial Co., Ltd.·Product code EBZ·2014-10-07
K140304 — SIMPLY SLICK PERSONAL LUBRICATING LOTIONSimply Solutions, LLC·Product code NUC·2014-10-07
K140467 — FLEX-MT +Emsi·Product code IPF·2014-10-07
K141160 — A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITORA & D Co., Ltd.·Product code DXN·2014-10-07
K141510 — EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)Eco Medi Glove Sdn. Bhd.·Product code LZA·2014-10-07
K141623 — EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIMEco Medi Glove Sdn. Bhd.·Product code LZA·2014-10-07
K141699 — VASSEN COLORVassen Co., Ltd.·Product code LPL·2014-10-07
K141739 — RESIDUAL LIMB LENGTHENING SYSTEMEllipse Technologies, Inc.·Product code HSB·2014-10-07
K142027 — 888 WNLE POWERED WHEELCHAIRPihsiang Machinery Mfg. Co., Ltd.·Product code ITI·2014-10-07
K142275 — Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact LensNeo Vision Co., Ltd.·Product code LPL·2014-10-07
K142353 — First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup TestW.H.P.M., Inc.·Product code DIO·2014-10-07
K141522 — APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIESApex Medical Corp.·Product code BZD·2014-10-06
K141704 — NOVASHIELD INJECTABLE NASAL PACKING AND STENTMedtronic, Inc.·Product code LYA·2014-10-06
K141708 — ULTRASHAPE SYSTEMSyneron Medical, Ltd.·Product code OHV·2014-10-06
K141842 — STARBAND, STARLIGHTOrthomerica Products, Inc.·Product code MVA·2014-10-06
K141894 — SHARKCORE FINE NEEDLE BIOPSY SYSTEMCovidien, LLC( Formerly Beacon Endoscopic Corp.)·Product code FCG·2014-10-06
K141973 — DIODE LASER HAIR REMOVAL SYSTEMBeijing Anchorfree Technology Co., Ltd.·Product code GEX·2014-10-06
K142538 — LiNA SafeAir Smoke PencilLina Medical Aps·Product code GEI·2014-10-06
K133975 — MSA100 PEAK FLOW METERBeijing M&B Electronic Instruments Co., Ltd.·Product code BZH·2014-10-03
K140062 — FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBERFsc Laboratories, Inc.·Product code NVP·2014-10-03
K140309 — CRANIOPLUGOssdsign AB·Product code GXR·2014-10-03
K140605 — MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERCDima Italia Srl·Product code NHJ·2014-10-03
K141139 — SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETERZoll Circulation·Product code NCX·2014-10-03
K141297 — FORUM GLAUCOMA WORKPLACECarl Zeiss Meditec, AG·Product code NFJ·2014-10-03
K141502 — HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTYOrthocon, Inc.·Product code MTJ·2014-10-03
K141743 — FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KITRadiology Solutions, LLC·Product code MQB·2014-10-03
K141765 — FDR D-EVO FLAT PANEL DETECTOR SYSTEMFujifilm Medical Systems U.S.A, Inc.·Product code MQB·2014-10-03
K142304 — Viberect Penile Vibratory Stimulation DeviceReflexonic, LLC·Product code KXQ·2014-10-03
K142442 — MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEMZimmer, Inc.·Product code HWC·2014-10-03
K142466 — UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.·Product code IYN·2014-10-03
K142534 — HyProCure IIGraham Medical Technologies, LLC Dba Gramedica·Product code HWC·2014-10-03
K142536 — 21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)Jvckenwood Corporation·Product code PGY·2014-10-03
K142540 — 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)Jvckenwood Corporation·Product code PGY·2014-10-03
K140530 — Electro Auricular DeviceNavigant Consulting, Inc.·Product code BWK·2014-10-02
K140908 — JUGGERKNOT MINI SOFT ANCHORBiomet Sports Medicine·Product code DZL·2014-10-02
K141200 — PADI-LOCKPadi-Lock, LLC·Product code FPA·2014-10-02
K141347 — EMERGE MEDICAL IM NAIL SYSTEMEmerge Medical·Product code HSB·2014-10-02
K141542 — NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )Covidien, LLC·Product code DQA·2014-10-02
K141664 — SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSIONRexam Healthcare·Product code MEG·2014-10-02
K142268 — Varian Verification System (VVS)Varian Medical Systems, Inc.·Product code IYE·2014-10-02
K142302 — BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test SystemPolymer Technology Systems, Inc.·Product code CGA·2014-10-02
K140577 — INNESIS PEEK TL CAGEBk Meditech, Co., Ltd.·Product code MAX·2014-10-01
K142364 — Barrx RFA Self Sizing Balloon CatheterCovidien, LLC·Product code GEI·2014-10-01
K142450 — DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.·Product code ODP·2014-10-01
K142460 — EXPEDIUM Spine System/Synapse SystemJohnson and Johnson·Product code KWP·2014-10-01
K130450 — SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVEPurna Bina Sdn Bhd·Product code KGO·2014-09-30
K140371 — FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)Abbott Diabetes Care, Inc.·Product code NBW·2014-09-30
K141140 — COMP A-I-ROmron Healthcare, Inc.·Product code CAF·2014-09-30
K141286 — AER-O-SCOPE COLONOSCOPE SYSTEMGi View , Ltd.·Product code FDF·2014-09-30
K141422 — PROFLUORO FLUORIDE VARNISHPac-Dent International, Inc.·Product code LBH·2014-09-30
K141476 — WAVELIGHT FS200 LASER SYSTEMAlcon Research, Ltd. Dba Alcon Laboratories, Inc.·Product code OOE·2014-09-30
K141547 — WINGMAN EXTENDABLE TIP SUPPORT CATHETERReflow Medical·Product code DQY·2014-09-30
K141598 — FUSE COLONOSCOPY SYSTEMEndochoice, Inc.·Product code FDF·2014-09-30
K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHTDickson & Dickson Healthcare (Us), Inc.·Product code FSY·2014-09-30
K142113 — ESOPHYX2 HDEndogastric Solutions, Inc.·Product code ODE·2014-09-30
K142258 — PolyCatch Retrieval DeviceMedi-Globe Corporation·Product code FDI·2014-09-30
K141290 — HELICAL RIDGE PEEK INTERFERENCE SCREWMedShape, Inc.·Product code HWC·2014-09-29
K141314 — SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATIONSpineart·Product code OVE·2014-09-29
K141633 — PRO-PICC WITH VALVE TECHNOLOGYMedical Components, Inc.·Product code LJS·2014-09-29
K142054 — IMACOR ZURA EVO IMAGING SYSTEMImacor, Inc.·Product code IYO·2014-09-29
K142386 — Operating Room Light Handle AdapterLitex Manufacturing, Inc.·Product code FTA·2014-09-29
K131817 — EXTRACORPOREAL SHOCK WAVE LITHOTRIPTEROsmunda Medical Device Consulting Co., Ltd.·Product code LNS·2014-09-26
K133577 — CLYDESDALE(R) SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code MAX·2014-09-26

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