FDA 510(k) clearances — page 432

176,542 clearances on record, most recent first.

Clearances — page 432

43,101–43,200 of 176,542

K123466 — HEALTHVIEW ECG MANAGERLumedx·Product code DQK·2012-12-20
K123499 — AEROPILOTKonica Minolta Medical & Graphic, Inc.·Product code MQB·2012-12-20
K123528 — SCENIUMSiemens Medical Solutions USA, Inc.·Product code LLZ·2012-12-20
K123530 — MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)Hologic, Inc.·Product code LLZ·2012-12-20
K123585 — SYNGO, CT CARDIAC FUNCTIONSiemens Medical Solutions USA, Inc.·Product code JAK·2012-12-20
K123659 — TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)Actuated Medical, Inc.·Product code KNT·2012-12-20
DEN090007 — BIO-SEAL LUNG BIOPSY TRACT SYSTEMAngiotech·Product code OMT·2012-12-19
K112644 — SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEMLotus Bio, Ltd.·Product code MQK·2012-12-19
K113506 — IND ONE STEP OCCULT BLOOD (FOB) TESTInd Diagnostics, Inc.·Product code KHE·2012-12-19
K120628 — HELIOMotion Composites·Product code IOR·2012-12-19
K120985 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONINGKimberly-Clark Corp.·Product code BTR·2012-12-19
K121369 — NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATORIbramed Equipamentos Medicos·Product code GZJ·2012-12-19
K121803 — INTRAVASCULAR ADMINISTRATION SETActa Medical, LLC·Product code FPA·2012-12-19
K122217 — CERTUS 140 2.45GHZ ABLATION SYSTEMNeuwave Medical, Inc.·Product code NEY·2012-12-19
K122321 — BASIXCONPAK ANALOG INFLATION SYRINGEMerit Medical Ireland, Ltd.·Product code MAV·2012-12-19
K122376 — PMT TRUSCAN SURFACE ELECTRODEPmt Corp.·Product code GXY·2012-12-19
K122603 — ONTEX AND OTHER PROPRIETARY NAMESOntex Bvba·Product code HEB·2012-12-19
K122832 — MOBICATH TRANSSEPTAL NEEDLEGreat Batch Medical·Product code DRC·2012-12-19
K122954 — CINCHER-2.6 SUTURE ANCHOR MODEL FG-001Foundry Newcoxi, Inc.·Product code MBI·2012-12-19
K123184 — FINN CHAMBERS AQUASmartpractice·Product code KXF·2012-12-19
K123359 — OVS1 VIDEO SYSTEMOlive Medical Corp.·Product code FCW·2012-12-19
K113743 — EVOLUTION 3E VENTILATOREvent Medical, Inc.·Product code CBK·2012-12-18
K121105 — NUTRISAFE 2 FEEDING TUBEVygon Corp.·Product code FPD·2012-12-18
K121278 — HERMES MEDICAL IMAGING SUITE V5.2Hermes Medical Solutions AB·Product code KPS·2012-12-18
K122734 — AESCULAP NOVOSYN ABSORBABLE SUTUREAesculap, Inc.·Product code GAM·2012-12-18
K122794 — UPSYLON Y MESHBoston Scientific Corp·Product code OTO·2012-12-18
K122813 — HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMCincinnati Sub-Zero Products, Inc.·Product code DWC·2012-12-18
K122875 — ORICARE L2700Oricare, Inc.·Product code FSY·2012-12-18
K122968 — NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015Coloplast Corp.·Product code OTO·2012-12-18
K123318 — IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTERCovidien, Formerly US Surgical A Divison of Tyco H·Product code GDW·2012-12-18
K123398 — DR. SCHOLL'S COMPRESSION SOCKSRenfro Corporation·Product code DWL·2012-12-18
K123561 — ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESSBsn Medical, Inc.·Product code DWL·2012-12-18
K123564 — LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEMGE Healthcare·Product code IYN·2012-12-18
K123568 — VERTEX RECONSTRUCTION SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code KWP·2012-12-18
K123695 — TRAUS SIP10Saeshin Precision Co., Ltd.·Product code EKY·2012-12-18
K110215 — CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODYVentana Medical Systems, Inc.·Product code MYA·2012-12-17
K120886 — LACRIFASTHiroyasu Higuchi·Product code OKS·2012-12-17
K120946 — ALPHA CRYPTOCOCCAL ANTIGEN EIAImmuno-Mycologics, Inc.·Product code MDU·2012-12-17
K120955 — COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEMAesculap Implant Systems, LLC·Product code JWH·2012-12-17
K122211 — SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSSynthes Spine·Product code HAW·2012-12-17
K122509 — VERTIFLEX SPINOUS PROCESS FIXATION PLATEVertiflex, Inc.·Product code KWP·2012-12-17
K100404 — ASCENDX VCF REDUCTION SYSTEMAoi Medical, Inc.·Product code NDN·2012-12-14
K113018 — APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORMBEIJING SYNTECH LASER CO., LTD.·Product code GEX·2012-12-14
K113313 — MOLECULAR ADSORBENT RECIRCULATING(MARS)Gambro Renal Products, Inc.·Product code FLD·2012-12-14
K113377 — GLIADIN IGA AND GLIADIN LGAGrifols USA, LLC·Product code MST·2012-12-14
K113779 — CONELOG IMPLANT SYSTEMAltatec GmbH·Product code DZE·2012-12-14
K121117 — NDX ABUTMENTSNational Dentex Corp·Product code NHA·2012-12-14
K121498 — PERCUNAVPhilips Health Care·Product code JAK·2012-12-14
K121514 — ANODYNE ANTERIOR CERVICAL PLATE SYSTEMCorelink, LLC·Product code KWQ·2012-12-14
K121623 — BIPAP A 40 VENTILATORY SUPPORT SYSTEMRespironics, Inc.·Product code MNT·2012-12-14
K121955 — COUGHASSIST T70 DEVICERespironics, Inc.·Product code NHJ·2012-12-14
K122152 — OXTI INFLATION DEVICEOxti Corporation·Product code MAV·2012-12-14
K122753 — EMPOWER CLEARAmerican Orthodontics·Product code NJM·2012-12-14
K122827 — AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811Medtronic, Inc.·Product code DTZ·2012-12-14
K122831 — VIDEO SYSTEM CENTEROlympus Medical Systems Corp.·Product code NTN·2012-12-14
K122840 — CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407Mick Radio-Nuclear Instruments, Inc.·Product code JAQ·2012-12-14
K122937 — SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)Cook, Inc.·Product code DQO·2012-12-14
K123010 — ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMACON Laboratories, Inc.·Product code NBW·2012-12-14
K123065 — CATHETER CONNECTIONS DUALCAP SOLOCatheter Connections, Inc.·Product code QBP·2012-12-14
K123203 — MAXLOCK EXTREME SYSTEM MODEL MXLOrthohelix Surgical Designs, Inc.·Product code HRS·2012-12-14
K123257 — EMVERA DIOLUXEmvera Technologies, Inc.·Product code GEX·2012-12-14
K123319 — GYRUS ACMI BICOAG HEMOSTASIS PROBEOlympus Surgical Technologies America·Product code KNS·2012-12-14
K123385 — MEDILAS H LASER FIBERSDornier Medtech America, Inc.·Product code GEX·2012-12-14
K123531 — UNBALLOON NON-OCCLUSIVE MODELING CATHETERLeMaitre Vascular, Inc.·Product code DQY·2012-12-14
K123532 — OCELOT PIXL CATHETERAvinger, Inc.·Product code PDU·2012-12-14
K113771 — SIGNAL GEAR URETHRAL CATHETER ELECTRODENeurovision Medical Products, Inc.·Product code FAP·2012-12-13
K120844 — MEDLINX SURGICAL MESHMedlinx Acala Pte, Ltd.·Product code FTL·2012-12-13
K120936 — ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORSMicrogenics Corporation·Product code DKB·2012-12-13
K121218 — HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,Andrew Technologies, LLC·Product code QPB·2012-12-13
K121398 — CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)Guidepath Medical, Inc.·Product code DQX·2012-12-13
K121853 — DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESDefibtech, LLC·Product code MKJ·2012-12-13
K122269 — ENAMICVita Zahnfabrik H.Rauter GmbH & Co.·Product code EIH·2012-12-13
K122459 — PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEMBoston Scientific Corporation·Product code OTP·2012-12-13
K122535 — FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530HFujifilm Medical System U.S.A., Inc.·Product code EOQ·2012-12-13
K122613 — VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/USToshiba America Medical Systems, In.C·Product code LNH·2012-12-13
K122821 — CELLTRACKS AUTOPREP SYSTEMVeridex, LLC·Product code NQI·2012-12-13
K122839 — ZOLL SUREPOWER SINGLE BAY CHARGERZOLL Medical Corporation·Product code MKJ·2012-12-13
K122869 — MILAGRO INTERFERENCE SCREWSDepuy Mitek, A Johnson & Johnson Company·Product code MAI·2012-12-13
K122958 — DELIVERY SHEATH, MODEL ADELANTE BREEZEWAYOscor, Inc.·Product code DYB·2012-12-13
K122960 — STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINOOscor, Inc.·Product code DYB·2012-12-13
K123094 — ORTHODONTIC CERAMIC BRACKETSTomy, Inc.·Product code NJM·2012-12-13
K123156 — GORE FLOW REVERSAL SYSTEM MODEL GFRS073W. L. Gore & Associates, Inc.·Product code NTE·2012-12-13
K123355 — AMPLIVUE C. DIFFICILE ASSAYQuidel Corporation·Product code OZN·2012-12-13
K123448 — AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVEMedtronic, Inc.·Product code DTL·2012-12-13
K123492 — DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)Philips Medical Systems·Product code MOS·2012-12-13
K123493 — VEX-S 100W INTRAORAL X-RAY SYSTEMVATECH Co., Ltd.·Product code EHD·2012-12-13
K123503 — DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEMShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYN·2012-12-13
K123565 — PRESTO 1000 SYSTEMPhysiosonics, Inc.·Product code IYN·2012-12-13
K112695 — CRYOTOPKitazato Biopharma Co;Ltd·Product code MQK·2012-12-12
K120956 — VSP SYSTEMMedical Modeling, Inc.·Product code DZJ·2012-12-12
K121152 — SURGICAL GOWN, SMSJiangsu Guangda Medical Material, Co., Ltd.·Product code FYA·2012-12-12
K121508 — LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-NFotona D.D.·Product code PDZ·2012-12-12
K121842 — ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1CAxis-Shield Diagnostics, Ltd.·Product code LCP·2012-12-12
K122000 — HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVERChangzhou Holymed Products Co., Ltd.·Product code KKX·2012-12-12
K122213 — ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEARSoflex Limited·Product code LPL·2012-12-12
K122423 — VASU-PICCMedical Components, Inc.·Product code LJS·2012-12-12
K122555 — STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPESteritec Products Mfg Co, Inc.·Product code JOJ·2012-12-12
K122571 — MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEMSeaspine, Inc.·Product code NKB·2012-12-12
K122649 — NAVIGATOR HD URETERAL ACCESS SHEATH SETBoston Scientific Corp·Product code FED·2012-12-12
K122855 — TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTSStraumann USA·Product code DZE·2012-12-12

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