FDA 510(k) clearances — page 461

176,542 clearances on record, most recent first.

Clearances — page 461

46,001–46,100 of 176,542

K113146 — PCXX VARNISHRoss Healthcare, Inc.·Product code LBH·2012-01-23
K113301 — CONCENPIECE,HIGH-SPEED HANDPIECE SERIESDentalez, Inc.·Product code EFB·2012-01-23
K113661 — LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLSLin-Zhi International, Inc.·Product code LAF·2012-01-23
DEN120008 — STRATIFY JCV(TM) ANTIBODYFocus Diagnostics, Inc.·Product code OYP·2012-01-20
K103697 — TORQTECHJ. Morita USA, Inc.·Product code EGS·2012-01-20
K110406 — CELLTRACKS AUTOPREP SYSTEMVeridex, LLC·Product code NQI·2012-01-20
K110874 — ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATORSiemens Healthcare Diagnostics, Inc.·Product code JZG·2012-01-20
K110896 — RELIANCE SPINAL SCREW SYSTEMReliance Medical Systems, LLC·Product code MNI·2012-01-20
K111202 — SURGICAL TISSUE MANAGEMENT SYSTEMOlympus Medical Systems Corp.·Product code GEI·2012-01-20
K112161 — AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..Radiometer Medical Aps·Product code KHO·2012-01-20
K112343 — TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics, Inc.·Product code LIP·2012-01-20
K112662 — MICROFRANCE(R) WORMALD VASCULAR CLAMPMedtronic Xomed, Inc.·Product code DXC·2012-01-20
K112725 — LIAISON 25 OH VITAMIN D TOTAL ASSAYDiaSorin, Inc.·Product code MRG·2012-01-20
K112918 — DURABLUE STERILIZATION (AMSCO V-PRO) WRAPCardinal Health200, LLC·Product code FRG·2012-01-20
K112934 — NEUROTECH RECOVERYBio-Medical Research, Ltd.·Product code GXY·2012-01-20
K112936 — SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEMRexam Consummer Plastics Inc.D/B/A Rexam Pharma·Product code MEG·2012-01-20
K113132 — DISPOSABLE HEMOSTATIC Y-CONNECTORSCoeur, Inc.·Product code DTL·2012-01-20
K113294 — SMITH & NEPHEW HEALICOIL PK SUTURE ANCHORSmith & Nephew, Inc.·Product code MBI·2012-01-20
K113302 — NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORSNorth American Science Assoc., Inc.·Product code FRC·2012-01-20
K113480 — SPECTRA OPTIA APHERESIS SYSTEMCaridianbct, Inc..·Product code LKN·2012-01-20
K113509 — LEXUS ANTERIOR CERVICAL PLATE SYSTEML&K BIOMED Co., Ltd.·Product code KWQ·2012-01-20
K113527 — OPTICAGE INTERBODY FUSION DEVICEInterventional Spine, Inc.·Product code MAX·2012-01-20
K113645 — REGENEROSS ALLOGRAFT PLUS MINERLIZEDBiomet Interpore Cross·Product code NUN·2012-01-20
K113709 — MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECEBiolitec Medical Devices, Inc.·Product code GEX·2012-01-20
K113769 — GPSCATH BALLON DILATATION CATHETERHotspur Technologies·Product code LIT·2012-01-20
K113800 — QUILL QUADRAHELIX TISSUE-CLOSURE DEVICEAngiotech·Product code GAW·2012-01-20
K111157 — CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASESCarl Zeiss Meditec, Inc.·Product code OBO·2012-01-19
K111681 — HISTOBRUSHPuritan Medical Products Company, LLC·Product code HHT·2012-01-19
K111719 — OASYS SPINAL SYSTEMStryker Spine·Product code KWP·2012-01-19
K112300 — KIMGUARD SMART-FOLD* STERILIZATION WRAPKimberly-Clark Corp.·Product code FRG·2012-01-19
K112348 — RS-4I MUSCLE STIMULATORRs Medical·Product code IPF·2012-01-19
K112868 — DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAXDreamgard, Inc.·Product code MQC·2012-01-19
K113083 — TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORTruly Instrument Co., Ltd.·Product code DXN·2012-01-19
K113173 — NANOVIS SPINAL SYSTEMNanovis, LLC·Product code NKB·2012-01-19
K113792 — MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBEBiolitec Medical Devices, Inc.·Product code GEX·2012-01-19
K120010 — CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)Shenzhen Med-Link Electronics Tech Co., Ltd.·Product code DSA·2012-01-19
K110017 — AG-608N BLOOD GLUCOSE MONITORING SYSTEMAndon Medical Co., Ltd.·Product code NBW·2012-01-18
K111221 — MISSION U500 URINE ANALYZERACON Laboratories, Inc.·Product code JIO·2012-01-18
K111286 — QUASAR CALYPSOSilver Bay, LLC·Product code OLP·2012-01-18
K111407 — TRIPORT, TRIPORT+, TRIPORT15, QUADPORTAdvanced Surgical Concepts·Product code OTJ·2012-01-18
K111494 — HANDHELD PULSE OXIMETERBeijing Choice Electronic Technololgy Co., Ltd.·Product code DQA·2012-01-18
K112612 — POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIMTop Calibre Sdn Bhd·Product code LYY·2012-01-18
K112825 — AVITA ARM TYPE BLOOD PRESSURE MONITORAvita Corporation·Product code DXN·2012-01-18
K113773 — ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOLSt Jude Medical·Product code KRA·2012-01-18
K112441 — COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEMDaesung Maref Co., Ltd.·Product code IRP·2012-01-17
K112716 — OSTEON IIGenoss Co., Ltd.·Product code LYC·2012-01-17
K112814 — CUFFINKCayenne Medical, Inc.·Product code MBI·2012-01-17
K113098 — AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS IIIApex BioTechnology Corp.·Product code NBW·2012-01-17
K113101 — EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALLBoston Scientific Corporation·Product code DSY·2012-01-17
K113248 — AERODR SYSTEM WITH P-21Konica Minolta Medical & Graphic, Inc.·Product code KPR·2012-01-17
K113252 — PEEK PREVAIL CERVICAL INTERBODY DEVICEMedtronic Sofamor Danek·Product code OVE·2012-01-17
K113329 — K2M, PYRENEES CERVICAL PLATE SYSTEMK2m, Inc.·Product code KWQ·2012-01-17
K113366 — LEUCADIA AUTOLOK PEDICLE SCREW SYSTEMPhygen, LLC·Product code NKB·2012-01-17
K113497 — HYPERIONCefla S.C. Cefla Dental Group·Product code MUH·2012-01-17
K113730 — PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORSParcus Medical, LLC·Product code MBI·2012-01-17
K110083 — V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODERespironics California, Inc.·Product code CBK·2012-01-13
K110305 — CRY-ACTRACKERCAMBrymill Cryogenic Cystems·Product code FQZ·2012-01-13
K110480 — PDE PHOTODYNAMIC EYEHamamatsu Photonics K.K.·Product code OWN·2012-01-13
K111162 — SLIM ONEBODY SYSTEMDentium Co., Ltd.·Product code DZE·2012-01-13
K111381 — MEDI-SIS SYRINGE INFUSION SYSTEMAcacia, Inc.·Product code LZH·2012-01-13
K111788 — ENDOEYE HD IIOlympus America, Inc.·Product code HET·2012-01-13
K112013 — EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASERBiolitec, Inc.·Product code GEX·2012-01-13
K112114 — MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40Maquet Critical Care AB·Product code BSZ·2012-01-13
K112189 — THERMO PAL INFRARED EAR THERMOMETERDigio2 International Co., Ltd.·Product code FLL·2012-01-13
K112417 — VARIOUSDepuy Mitek, A Johnson & Johnson Company·Product code MBI·2012-01-13
K112677 — THE VENOUS ASSIST SYSTEMDaesung Maref Co., Ltd.·Product code JOW·2012-01-13
K112707 — GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEMOrtho Technology, Inc.·Product code NJM·2012-01-13
K112727 — MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICALMedical Facets·Product code HWC·2012-01-13
K112730 — ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTIONBiomet 3i·Product code NHA·2012-01-13
K112852 — BABI PLUS NEONATAL RESUSCITATION BAGA Plus Medical·Product code BTM·2012-01-13
K113086 — ACQATexas Medical Imaging Consultants·Product code KPS·2012-01-13
K113093 — VANTAGE TITAN 3TToshibamedical Systems Corporation·Product code LNH·2012-01-13
K113410 — NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENTStraumann USA·Product code NHA·2012-01-13
K113490 — OPTIMA MR450WGe Medical Systems, LLC·Product code LNH·2012-01-13
K113698 — SCEPTER XC OCCLUSION BALLOON CATHETERMicroVention, Inc.·Product code MJN·2012-01-13
K120011 — HEISENBERG EFFECT SHADES3M Espe AG·Product code EIH·2012-01-13
K100437 — AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTIONBestgen Biotech Corp.·Product code NBW·2012-01-12
K102439 — FUNNEL GUIDE CATHETER MODEL G1020608Lazarus Effect, Inc.·Product code DQY·2012-01-12
K110888 — ABSOLUTE WHITE LIGHTDr. Fresh, Inc.·Product code EEG·2012-01-12
K111992 — CUROS PORT PROTECTORIvera Medical, Inc.·Product code QBP·2012-01-12
K113085 — TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITORTruly Instrument Co., Ltd.·Product code DXN·2012-01-12
K113123 — OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEMThe Orthopaedic Implant Company·Product code KTT·2012-01-12
K113318 — ACUTE INNOVATIONS MODULAR RIBLOC SYSTEMAcute Innovations, LLC·Product code HRS·2012-01-12
K113330 — CABLECAPSensormed·Product code FST·2012-01-12
K113654 — CASPIANK2m, Inc.·Product code KWP·2012-01-12
K113667 — CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATINGEdwards Lifesciences, LLC·Product code DTL·2012-01-12
K113679 — LUCEA LED SURGICAL LIGHT SYSTEMMaquet S.A.S.·Product code NTN·2012-01-12
K113683 — LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEALHospira, Inc.·Product code FPA·2012-01-12
K113699 — TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTEDThe Procter & Gamble Company·Product code HEB·2012-01-12
K111794 — REPROCESSED HARMONIC SCALPELSterilmed, Inc.·Product code NLQ·2012-01-11
K112256 — STERIS STEAM PISTERIS Corporation·Product code JOJ·2012-01-11
K112811 — SANICLAVE 200Alternative Pioneering Research and Development·Product code FLE·2012-01-11
K113069 — COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAYBiomet Manufacturing Corp·Product code PHX·2012-01-11
K113405 — SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEMSuspension Orthopaedic Solutions, LLC·Product code HRS·2012-01-11
K113460 — SYNERGY TISSUE MATRIXSynovis Orthopedic & Woundcare·Product code FTM·2012-01-11
K113651 — INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEMBoston Scientific Corporation·Product code KRD·2012-01-11
K113681 — GLADIATOR PTA BALLOON DILATION CATHETERBoston Scientific·Product code LIT·2012-01-11
K103695 — PREPEX SYSTEMCirc Medtech·Product code HFX·2012-01-10
K110581 — PROPATCH SOFT TISSUE REPAIR MATRIXCryolife, Inc.·Product code FTM·2012-01-10
K110971 — TRACER IMPLANTATION KIT, INDEX IMPLANTATION KITNavotek Medical, Ltd.·Product code IYE·2012-01-10

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