FDA 510(k) clearances — page 384

176,542 clearances on record, most recent first.

Clearances — page 384

38,301–38,400 of 176,542

K140531 — BIOFOAM BONE WEDGEWrightmedicaltechnologyinc·Product code HRS·2014-07-09
K140917 — INTRODUCER, MODEL ADELANTE MAGNUMOscor, Inc.·Product code DYB·2014-07-09
K141245 — ETEX MIXING AND DELIVERY SYSTEMEtex Corporation·Product code FMF·2014-07-09
K141417 — CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREWWrightmedicaltechnologyinc·Product code HRS·2014-07-09
K141444 — IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CALSiemens Healthcare Diagnostics, Inc.·Product code JJX·2014-07-09
K132761 — WIRELESS THERMOMETERRaiing Medical Company·Product code FLL·2014-07-08
K133811 — RESTORIS POROUS PARTIAL KNEE SYSTEMMako Surgical Corp.·Product code NJD·2014-07-08
K140144 — BENDA WEDGECentrix, Inc.·Product code EJB·2014-07-08
K140643 — GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGYDepuy Mitek, A Johnson and Johnson Company·Product code MAI·2014-07-08
K140816 — POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)Better Care Plastic Technology Co., Ltd.·Product code LZA·2014-07-08
K141102 — HOSPIRA MEDNET MEDICATION MANAGEMENT SUITEHospira, Inc.·Product code FRN·2014-07-08
K141117 — EZ-IO INTRAOSSEOUS INFUSION SYSTEMVidacare, LLC·Product code FMI·2014-07-08
K141151 — CT MIDLINEMedcomp (Medical Components, Inc.)·Product code LJS·2014-07-08
K141228 — AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREWAdvanced Orthopaedic Solutions, Inc.·Product code HSB·2014-07-08
K141273 — WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTEWelldoc, Inc.·Product code MRZ·2014-07-08
K141478 — ARTHREX FRACTURE PLATES AND SCREWSArthrex, Inc.·Product code HRS·2014-07-08
K141618 — ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUSArrow International, Inc (Subsidiary of Teleflex I·Product code OBJ·2014-07-08
K131601 — DELL U3014 WITH QUBYX PERFECTLUM BUNDLEQubyx Limited·Product code PGY·2014-07-07
K132214 — ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVEHager& Meisinger GmbH·Product code NHA·2014-07-07
K132778 — GRAB 'N GO PLUS, GRAB 'N GO DIGITALPraxair Healthcare Services·Product code ECX·2014-07-07
K133299 — ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLYFresenius Medical Care, North America - Renal Ther·Product code KDI·2014-07-07
K133648 — SYNGO, CT DUAL ENERGYSiemens Medical Solutions USA, Inc.·Product code JAK·2014-07-07
K133784 — VISTA-S DEVICE, ASSOCIATED INSTRUMENTATIONZimmer Trabecular Metal Technology·Product code ODP·2014-07-07
K140324 — RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XLDepuy Mitek, A Johnson and Johnson Company·Product code MBI·2014-07-07
K140785 — PULSE OXIMETERNonin Medical, Inc.·Product code DQA·2014-07-07
K141051 — VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HUArrow International, Inc.·Product code MSD·2014-07-07
K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSHMaquet Cardiopulmonary, AG·Product code DTN·2014-07-07
K131923 — NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENSTechlink International·Product code GZI·2014-07-03
K132543 — INFANT INCUBATORBistos Co., Ltd.·Product code FMZ·2014-07-03
K132881 — Z5CZ-Systems AG·Product code DZE·2014-07-03
K132987 — COBRA FUNDUS CAMERAC.S.O. S.R.L.·Product code HKI·2014-07-03
K133114 — MICROPUNCTURE INTRODUCER SETCook Incorporated·Product code DYB·2014-07-03
K133528 — H&H EMERGENCY CRICOTHYROTOMY KITH & H Medical Corporation·Product code JOH·2014-07-03
K133689 — POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINKPt. Medisafe Technologies·Product code LZA·2014-07-03
K133835 — ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEMArthrosurface, Inc.·Product code HTN·2014-07-03
K140141 — LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEMCeragem Medisys, Inc.·Product code NBW·2014-07-03
K140241 — EDWARDS TRANSFEMORAL BALLOON CATHETEREdwards Lifesciences, LLC·Product code OZT·2014-07-03
K140333 — ASCENDNeurometrix, Inc.·Product code NUH·2014-07-03
K140641 — VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMABoston Scientific Corporation·Product code DYB·2014-07-03
K140652 — POROUS COATED COMPREHENSIVE FRACTURE STEMSBiomet Manufacturing Corp·Product code PHX·2014-07-03
K140869 — DCAS IGp&P Co., Ltd.·Product code LLZ·2014-07-03
K140902 — E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEGBiomet, Inc.·Product code JWH·2014-07-03
K140962 — NORMED VARIO SUBTALAR SCREWNormed Nedizin Technik GmbH·Product code HWC·2014-07-03
K141134 — POD SYSTEMPenumbra, Inc.·Product code HCG·2014-07-03
K132384 — U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULAEndosec Corporation·Product code HIH·2014-07-02
K133110 — EXPRESS LD BILIARY PREMOUNTED STENT SYSTEMBoston Scientific Corporation·Product code FGE·2014-07-02
K133861 — FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CMOstial Corporation·Product code LIT·2014-07-02
K140055 — ENDOSKELETON(R) TL INTERBODY FUSION DEVICETitan Spine, LLC·Product code MAX·2014-07-02
K140121 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORAndon Health Co, Ltd.·Product code DXN·2014-07-02
K140129 — PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETERIcu Medical, Inc.·Product code DQE·2014-07-02
K140162 — AP EXPANDABLE XLIF SYSTEMNuvasive, Inc.·Product code MAX·2014-07-02
K140260 — SKYHAWK LATERAL PLATE SYSTEMOrthofix, Inc.·Product code KWQ·2014-07-02
K140351 — ARROW GPSCATH BALLOON DILATATION CATHETERHotspur Technologies,Inc Subsidiary of Teleflex ME·Product code LIT·2014-07-02
K140512 — UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITEJuno Dentistry LP·Product code EBF·2014-07-02
K140572 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITORMicrolife Intellectual Property GmbH, Switzerland·Product code DXN·2014-07-02
K140596 — NAVIOBlue Belt Technologies, Inc.·Product code OLO·2014-07-02
K140601 — FLOW-NAILFlow-Fx, LLC·Product code HSB·2014-07-02
K140685 — ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEMSybron Endo·Product code NYL·2014-07-02
K140849 — ISOSEEDEckert & Ziegler Bebig GmbH·Product code KXK·2014-07-02
K140909 — MCKESSON RADIOLOGYMckesson Medical Imaging Company·Product code LLZ·2014-07-02
K141369 — VISIQ DIAGNOSTIC ULTRA SOUND SYSTEMPhilips Ultrasound, Inc.·Product code IYN·2014-07-02
K141392 — SPHYGMOMANOMETERSuzhou JJ Meter Co., Ltd.·Product code DXQ·2014-07-02
K141452 — LEFORTE NEURO SYSTEM BONE PLATE AND SCREWJeil Medical Corporation·Product code GWO·2014-07-02
K141485 — ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLEGalil Medical , Ltd.·Product code GEH·2014-07-02
K141499 — X-REPAIRSLSynthasome, Inc.·Product code FTL·2014-07-02
K141556 — AVREO INTERWORKS SYSTEMAvreo, Inc.·Product code LLZ·2014-07-02
K141620 — RS80A DIAGNOSTIC ULTRASOUND SYSTEMSamsung Medison Co., Ltd.·Product code IYN·2014-07-02
K132036 — HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.·Product code MSX·2014-07-01
K132903 — DRE VENTURADre Medical, Inc.·Product code BSZ·2014-07-01
K133288 — CASPIAN OCT SPINAL SYSTEMK2m, Inc.·Product code KWP·2014-07-01
K133693 — DIGITAL RADIOGRAPHY CXDI-401C WIRELESSCanon, Inc.·Product code MQB·2014-07-01
K133916 — CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2Biosense Webster, Inc.·Product code DQK·2014-07-01
K140379 — MEGA BIG BOY CONDOMOkamoto USA, Inc.·Product code HIS·2014-07-01
K140400 — ES2 NEUROMONITORING ACCESSORY INSTRUMENTSStryker Corporation·Product code ETN·2014-07-01
K140411 — ALTERA SPACERGlobus Medical, Inc.·Product code MAX·2014-07-01
K140843 — DESARA BLUE OV, DESARA BLUE SSCaldera Medical·Product code OTN·2014-07-01
K141148 — EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SETCook Vascular, Inc.·Product code DRE·2014-07-01
K141234 — ODISSEY TISSUE OXIMETERVioptix, Inc.·Product code MUD·2014-07-01
K141406 — IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORSImmunalysis Corporation·Product code DJG·2014-07-01
K141458 — SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACKFocus Diagnostics·Product code PGH·2014-07-01
K124021 — ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEMArkray Factory, Inc.·Product code CGA·2014-06-30
K132354 — POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILEAdvanced Health Products, Lot 60 & 61·Product code LZA·2014-06-30
K132491 — MUELLER HINTON AGAREdge Biologicals, Inc.·Product code JTZ·2014-06-30
K132551 — ZF 720Umbel Corporation·Product code FSY·2014-06-30
K133189 — DUAL SHOT ALPHA 7Nemoto Kyorindo Co., Ltd.·Product code DXT·2014-06-30
K133575 — SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEMSpinevision S.A.·Product code MNH·2014-06-30
K140243 — SHUNTONGShuntong Glove Co., Ltd.·Product code LYZ·2014-06-30
K140674 — EXACTECH TAPERED WEDGE FEMORAL STEMExactech, Inc.·Product code LZO·2014-06-30
K140751 — MIROCAM CAPSULE ENDOSCOPE SYSTEMIntromedic Co., Ltd.·Product code NEZ·2014-06-30
K140833 — ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEMConformis, Inc.·Product code JWH·2014-06-30
K141045 — MBD PLATE SYSTEMMbd Medical, LLC·Product code HRS·2014-06-30
K141374 — BICARBONATE CALIBRATORBeckman Coulter Ireland, Inc.·Product code JIT·2014-06-30
K141395 — DELTA TT ACETABULAR SYSTEMLima Corporate S.P.A.·Product code LPH·2014-06-30
K141447 — PRECICE TRAUMA NAIL SYSTEMEllipse Technologies, Inc.·Product code HSB·2014-06-30
K130755 — HICUT HIGHSPEED INSTRUMENTAdeor Medical AG·Product code HBE·2014-06-27
K132195 — EUROIMMUN ANTI-PLA2R ELISA (IGG)Euroimmun Us, Inc.·Product code PGV·2014-06-27
K133260 — MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEMTianjin Empecs Medical Device Co., Ltd.·Product code NBW·2014-06-27
K133632 — PERICAN ULTRAB.Braun Medical, Inc.·Product code BSP·2014-06-27
K133843 — SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETERCordis Corporation·Product code LIT·2014-06-27
K133901 — PARI-PATH SURGICAL NAVIGATION SYSTEMParitic, Inc.·Product code JAK·2014-06-27

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