FDA 510(k) clearances — page 458

176,542 clearances on record, most recent first.

Clearances — page 458

45,701–45,800 of 176,542

K113275 — COMPRESSIBLE LIMB THERAPY SYSTEMWonjin Mulsan Co., Ltd.·Product code IRP·2012-02-27
K113276 — CATALYSTC-Rad Positioning AB·Product code IYE·2012-02-27
K113482 — JOURNEY II DEEP DISHED ARTICULAR INSERTSSmith & Nephew, Inc.·Product code JWH·2012-02-27
K113545 — VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HANDepuy Mitek, A Johnson & Johnson Company·Product code GEI·2012-02-27
K113844 — RADIFORCE RX240Eizo Nanao Corporation·Product code LLZ·2012-02-27
K112690 — BLOOD PRESSURE MONITORNihon Seimitsu Sokki Co., Ltd.·Product code DXN·2012-02-24
K112691 — BLOOD PRESSURE MONITORNihon Seimitsu Sokki Co., Ltd.·Product code DXN·2012-02-24
K112777 — SOL-M EXCHANGEABLE NEEDLESSol-Milennium Medical, Inc.·Product code FMI·2012-02-24
K112791 — SITESCRUB IPA DEVICEC. R. Bard·Product code LKB·2012-02-24
K112861 — SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEMSintea Plustek, LLC·Product code KWQ·2012-02-24
K113190 — TRU LEGIONELLAMeridian Bioscience, Inc.·Product code MJH·2012-02-24
K113203 — SONY LMD-2451MT LCD MONITORSony Electronics, Inc.·Product code GCJ·2012-02-24
K113254 — SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWSLima Corporate S.P.A.·Product code PHX·2012-02-24
K113408 — Q. FREEZE (MOTION VUE2)Ge Medical Systems, LLC·Product code KPS·2012-02-24
K113454 — 14 WIRE STANDARD, 14 WIRE LSMicro Therapeutics, Inc.·Product code DQX·2012-02-24
K113587 — AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)Shantou Wealy Medical Instrument Co.,Ltd·Product code MEG·2012-02-24
K113596 — MASIMO SET REUSABLE OXIMETRY SENSORSMasimo Corporation·Product code DQA·2012-02-24
K120229 — ENVOY DISTAL ACCESS GUIDING CATHETERCodman & Shurtleff, Inc.·Product code DQY·2012-02-24
K120241 — LINEAR HIP STEM, SIZE 5Encore Medical L.P.·Product code LPH·2012-02-24
K120242 — JETSTREAM NAVITUS L SYSTEMPathway Medical Technologies, Inc.·Product code MCW·2012-02-24
K120301 — MEDIGUIDE TECHNOLOGYSt. Jude Medical, Mediguide Navigation Systems·Product code DQK·2012-02-24
K120314 — WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEMWelldoc, Inc.·Product code MRZ·2012-02-24
K120343 — CONNEX WORKSTATIONWelch Allyn, Inc.·Product code MWI·2012-02-24
K120381 — Q50 PLUS STENT GRAFT BALLOON CATHETERQxmedical, LLC·Product code DQY·2012-02-24
K100624 — INVENDO C20 COLONOSCOPY SYSTEMInvendo Medical Gbmh·Product code FDF·2012-02-23
K110375 — BLUESHINE'S GOLD SERIESBlueshine Srl·Product code PDZ·2012-02-23
K111970 — KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENTTornier·Product code KRR·2012-02-23
K112758 — KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10Kat Implants, LLC·Product code DZE·2012-02-23
K112886 — UPSTREAM SUPPORT CATHETERUpstream Peripheral Technologies·Product code DQY·2012-02-23
K113222 — ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECENakamura Dental Handpiece Mfg. Co., Ltd.·Product code EFB·2012-02-23
K113430 — PROULTRA PIEZO ULTRASONICSatelec - Acteon Group·Product code ELC·2012-02-23
K113737 — SUREFIRE GUIDE SHEATHSurefire Medical, Inc.·Product code DQO·2012-02-23
K113805 — FIXATE TISSUE BANDAnulex Technologies, Inc.·Product code GZB·2012-02-23
K120019 — COLLAGEN RIBBONWrightmedicaltechnologyinc·Product code FTM·2012-02-23
K120027 — PILAIRO NASAL PILLOWS MASKFisher & Paykel Healthcare Limited·Product code BZD·2012-02-23
K110179 — INCONTROLIncontrol Medical, LLC·Product code KPI·2012-02-22
K111755 — VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)Ventana Medical Systems, Inc.·Product code NOT·2012-02-22
K112679 — SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEMMaterialise Dental NV·Product code LLZ·2012-02-22
K112812 — LEFORTE NEURO SYSTEM BONE PLATEJeil Medical Corporation·Product code GWO·2012-02-22
K113065 — RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTSBella Elevator, LLC·Product code ING·2012-02-22
K113514 — SMARTHEARTShl Telemedicine International , Ltd.·Product code DXH·2012-02-22
K113570 — INTEGRA CUSA NXT INFERIOR FOWARD BONE TIPIntegra Burlington Ma, Inc.·Product code LFL·2012-02-22
K113588 — SPECTRA LASER SYSTEMLutronic Corporation·Product code GEX·2012-02-22
K113757 — ASPIRE MAX ASPIRATION CATHETERControl Medical Technology, LLC·Product code QEZ·2012-02-22
K120189 — BONETRAPBerni Farns Incorporated·Product code KNW·2012-02-22
K111141 — BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITORWenzhou Bokang Instruments Co., Ltd.·Product code DXN·2012-02-21
K113520 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEMSTERIS Corporation·Product code MED·2012-02-21
K111421 — SIRONA DENTAL CAD/CAM SYSTEMSirona Dental Systems GmbH·Product code NHA·2012-02-17
K111463 — VALEO VT-601 SERIES IR THERMOMETERValeo Corp.·Product code FLL·2012-02-17
K111935 — TI-BASE ABUTMENT, 1 CONNECT ABUTMENTNt-Trading GmbH and CO KG·Product code NHA·2012-02-17
K111976 — VITEK 2 STREPTOCOCCUS ERYTHROMYCINbioMerieux, Inc.·Product code LON·2012-02-17
K112353 — GEODESIC EEG MOBILE 100 (GEM 100)Electrical Geodesics, Inc.·Product code GWQ·2012-02-17
K112654 — POWDERFREE POLYISOPRENE SURGICAL GLOVESPt. Medisafe Technologies·Product code KGO·2012-02-17
K112781 — TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)Luminex Molecular Diagnostics, Inc.·Product code OCC·2012-02-17
K113054 — EQUIVITALHidalgo Limited·Product code MHX·2012-02-17
K113206 — NANOBLUTM 500Draeger Medical Systems, Inc.·Product code LBI·2012-02-17
K113452 — ACU-CUT VERTEBRAL AUGMENTATION SYSTEMAscendx Spine, Inc.·Product code NDN·2012-02-17
K113505 — VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDERGreiner Bio-One North America, Inc.·Product code FMI·2012-02-17
K113556 — WAGNER CONE PROSTHESIS SYSTEMZimmer GmbH·Product code LZO·2012-02-17
K113627 — HEMASORB RESORBABLE HEMOSTATIC BONE PUTTYOrthocon·Product code MTJ·2012-02-17
K113664 — CLOSER TO NATURE ELECTRIC BREAST PUMPMayborn Group Limited·Product code HGX·2012-02-17
K120081 — NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADSCincinnati Sub-Zero Products, Inc.·Product code DWJ·2012-02-17
K120147 — ACE STAPLER AND CARTRIDGEBarosense, Inc.·Product code OCW·2012-02-17
K120155 — ARTHREX KNOTLESS SUTURETAK ANCHORArthrex, Inc.·Product code MBI·2012-02-17
K120163 — ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEMAcute Innovations, LLC·Product code HRS·2012-02-17
K120272 — AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SETKentec Medical, Inc.·Product code KNT·2012-02-17
K120321 — CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEMPhilips Health Care·Product code IYN·2012-02-17
K110404 — EAUM TOTAL KNEE SYSTEMCorentec Co., Ltd.·Product code JWH·2012-02-16
K110825 — PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODESPhilips Medical Systems·Product code MKJ·2012-02-16
K111448 — ICON (TM) MODULAR PEDICLE SCREW SYSTEMOrthofix, Inc.·Product code NKB·2012-02-16
K111473 — UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATORImpact Instrumentation, Inc.·Product code CBK·2012-02-16
K111521 — WAVESWaters Medical Systems, LLC·Product code KDN·2012-02-16
K111689 — STLASEDental Photonics, Inc.·Product code GEX·2012-02-16
K111860 — BD MAX GBS ASSAY, BD MAX INSTRUMENTBecton, Dickinson & CO·Product code NJR·2012-02-16
K111874 — FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMSAbbott Laboratories·Product code LFR·2012-02-16
K112271 — 3B WILLOW3B Products, LLC·Product code BZD·2012-02-16
K112330 — KOWA VX-20Kowa Co. , Ltd.·Product code HKI·2012-02-16
K112680 — EVIS EXERA III VIDEO SYSTEMOlympus Medical Systems Corporation·Product code FDF·2012-02-16
K112831 — PLEURX PLEURAL CATHETER SYSTEMSCare Fusion·Product code DWM·2012-02-16
K112841 — SURFACE BEACON TRANSPONDERSCalypso Medical Technologies, Inc.·Product code IYE·2012-02-16
K113419 — CS IMAGINGTrophy·Product code LLZ·2012-02-16
K113442 — 3DIShina Systems , Ltd.·Product code LLZ·2012-02-16
K113518 — ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEMSpinefrontier, Inc.·Product code ODP·2012-02-16
K113526 — CODMAN CERTAS PROGRAMMABLE VALVE SYSTEMMedos International SARL·Product code JXG·2012-02-16
K113701 — VISIA NEUROMeVis Medical Solutions AG·Product code LLZ·2012-02-16
K120121 — COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATEBiomet, Inc.·Product code PHX·2012-02-16
K120143 — ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICALApollo Spine·Product code ODP·2012-02-16
K120337 — I-PORT ADVANCE INJECTION PORTUnomedical A/S·Product code FOZ·2012-02-16
K120392 — CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KG·Product code FSY·2012-02-16
DEN120001 — IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASEPhadia US, Inc.·Product code OYL·2012-02-15
K110278 — CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900Nakanishi, Inc.·Product code EKX·2012-02-15
K110748 — OLYMPUS INSTRUMENT TRAYOlympus Winter & Ibe GmbH·Product code KCT·2012-02-15
K113378 — CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.·Product code JWH·2012-02-15
K113409 — S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAILHowmedica Osteonics Corp.·Product code HSB·2012-02-15
K113721 — TEPHAFLEX LIGHT MESHTepha, Inc.·Product code OOD·2012-02-15
K113723 — TEPHAFLEX MESHTepha, Inc.·Product code OOD·2012-02-15
K113724 — ELECTROPULSE-COSMETICPain Relief Technologies·Product code NFO·2012-02-15
K120140 — FOCUS SPINAL SYSTEML&K BIOMED Co., Ltd.·Product code NKB·2012-02-15
K111018 — POLYFUSE - NEUROBONEAtpac Medical, LLC·Product code MQV·2012-02-14
K111758 — CADENS (TM) COLONDog Microsystems, Inc.·Product code LLZ·2012-02-14

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