FDA 510(k) clearances — page 470

176,542 clearances on record, most recent first.

Clearances — page 470

46,901–47,000 of 176,542

K112652 — SURESIGNS VS2+ -SURESIGNS VSIPhilips Medical Systems·Product code DXN·2011-10-11
K102316 — GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEMBroadmaster Biotech Corporation·Product code CGA·2011-10-07
K102772 — DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)Siemens Heatlhcare Diagnostics, Inc.·Product code OAV·2011-10-07
K110471 — BABI PLUS INFANT NASAL CANNULA SYSTEMA Plus Medical·Product code BZD·2011-10-07
K110687 — RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)Acclarent, Inc.·Product code KAM·2011-10-07
K110780 — ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & IIElitechgroup·Product code CIG·2011-10-07
K110836 — CLS BREVIUS STEM WITH KINECTIV TECHNOLOGYZimmer GmbH·Product code KWA·2011-10-07
K111320 — GLOBALCARDIOCardiocomm Solutions, Inc.·Product code DSH·2011-10-07
K111404 — HUIBAO BODY FAT SCALEZhongshan Huibao Weighing Apparatus Co., Ltd.·Product code MNW·2011-10-07
K111419 — OSTEOMED HAND FUSION SYSTEMOsteomed LP·Product code HRS·2011-10-07
K111532 — MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECEAnthogyr Sas·Product code EGS·2011-10-07
K111640 — PRECISION FLOW(R) - HELIOXVapotherm, Inc.·Product code BTT·2011-10-07
K111784 — VENUS SWAN SYSTEMVenus Concept , Ltd.·Product code GEI·2011-10-07
K111859 — ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACKGalil Medical, Inc.·Product code GEH·2011-10-07
K112115 — MECTACER BIOLOX(R) DELTA FEMORAL HEADSMedacta International·Product code LZO·2011-10-07
K112263 — MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORYIntuitive Surgical, Inc.·Product code NAY·2011-10-07
K112446 — TOMOTHERAPY TREATMENT SYSTEMTomotherapy Incorporated·Product code MUJ·2011-10-07
K112460 — MULTIPLELarson Medical Products, Inc.·Product code IYE·2011-10-07
K112635 — U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONSKimberly-Clark Corp.·Product code HEB·2011-10-07
K112756 — FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERSGlobus Medical, Inc.·Product code MQP·2011-10-07
K112772 — ORTHOLOC(TM) BONE SCREWSWrightmedicaltechnologyinc·Product code HWC·2011-10-07
K101592 — ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEMCheng Medical, Corporation·Product code GXD·2011-10-06
K103485 — SENOGRAPH DS, SENOGRAPH ESSENSTIALGeneral Electric Company·Product code MUE·2011-10-06
K103625 — OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICEDraeger Medical Systems, Inc.·Product code CBK·2011-10-06
K103643 — ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)Ascot Technologies, Inc.·Product code DRG·2011-10-06
K110531 — ENDOFLIP ECDCrospon, Ltd.·Product code FED·2011-10-06
K110579 — ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLSAbbott Laboratories·Product code CDD·2011-10-06
K111266 — EASYLOCK OSTEOSYSTEMTriMed, Inc.·Product code HRS·2011-10-06
K111343 — CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSSCrosstex International, Inc.·Product code FXX·2011-10-06
K111371 — ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEMACON Laboratories, Inc.·Product code CGA·2011-10-06
K111566 — DRYVIEW CHROMA IMAGING SYSTEMCarestream Health, Inc.·Product code LMC·2011-10-06
K111647 — C2 NERVEMONITOR SYSTEM WITH ACCESSORIESInomed Medizintechnik GmbH·Product code GWF·2011-10-06
K112037 — RANGE SPINAL SYSTEM (MESA AND DENALI)K2m, Inc.·Product code MNI·2011-10-06
K112571 — XL EXTRACTION CATHETERVascular Solutions, Inc.·Product code QEZ·2011-10-06
K112579 — WILDCAT 5F GUIDEWIRE SUPPORT CATHETERAvinger, Inc.·Product code DQY·2011-10-06
K110819 — SINGHMED ROOLIP MANIPULATORJ.Singh Instruments·Product code HEW·2011-10-05
K111447 — ZIMMER PERIARTICULAR SCREWSZimmer, Inc.·Product code HWC·2011-10-05
K111740 — AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATIONAmeriwater·Product code FIP·2011-10-05
K111848 — EXETER X3 RIMFIT ACETABULAR CUPStryker Corp.·Product code JDI·2011-10-05
K112007 — CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2Biosense Webster, Inc.·Product code DQK·2011-10-05
K112173 — SPEACELABS MULTIGAS MODULESpacelabs Healthcare·Product code CBR·2011-10-05
K112715 — CANDELA GENTLEMAX FAMILY OF LASERSCandela Corp.·Product code GEX·2011-10-05
K103487 — FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TESTTaidoc Technology Corporation·Product code LCX·2011-10-04
K103651 — CARDIOMEDCardio Medical Products, Inc.·Product code LDD·2011-10-04
K110063 — SOVEREIGN SPINAL SYSTEMMedtronic Sofamor Danek, Inc.·Product code OVD·2011-10-04
K110870 — APLIO DIAGNOSTIC ULTRASOUND SYSTEM (3 models)Toshiba America Medical Systems, In.C·Product code IYN·2011-10-04
K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TESTTeco Diagnostics·Product code DIC·2011-10-04
K111378 — OXIMETRY INTERFACE KITPhilips Respironics, Inc.·Product code MNS·2011-10-04
K111551 — OEC(R) 9800, OEC(R) 9800 PLUSGe Oec Medical Systems, Inc.·Product code OWB·2011-10-04
K111583 — FLAATZ 560Drtech Corp.·Product code MQB·2011-10-04
K111662 — VENOTRAIN CURAFLOWBauerfeind AG·Product code DWL·2011-10-04
K111905 — INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216Philips Medizinsysteme Boeblingen GmbH, Cardiac AN·Product code DXJ·2011-10-04
K112116 — DIGITAL CLINICAL THERMOMETER MODEL V901USAmperor-Electronic(Sz) Co., Ltd.·Product code FLL·2011-10-04
K112456 — ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORTTeleflexmedical, Inc.·Product code GCJ·2011-10-04
K112703 — SHAKER DIGITAL THERMOMETERMeasure Technology Co. , Ltd.·Product code FLL·2011-10-04
K102871 — SILVER CARE ANITBACTERIAL TOOTHBRUSHPiave Spazzolificio S.P.A.·Product code EFW·2011-10-03
K103675 — CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVEChienmax Vietnam Co., Ltd.·Product code LZA·2011-10-03
K110308 — PROSTHETIC SYSTEMOsstem Implant Co., Ltd.·Product code NHA·2011-10-03
K110318 — EXCELLAGENTissue Repair Company·Product code KGN·2011-10-03
K110672 — ETWO SKIN TREATMENT SYSTEMSyneron, Ltd.·Product code GEI·2011-10-03
K111169 — PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMFKwang Myung Daicom, Inc.·Product code DZB·2011-10-03
K111357 — STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEMStraumann USA·Product code DZE·2011-10-03
K111606 — PINNACLE PRECISION ACCESS SYSTEMTerumo Medical Corp.·Product code DYB·2011-10-03
K111644 — MOBICATH TRANSSEPTAL NEEDLEGreat Batch Medical·Product code DRC·2011-10-03
K111735 — REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTEREncore Medical L.P.·Product code PHX·2011-10-03
K111899 — ARMADA 35/35LL PTA CATHETERAbbott Vascular·Product code LIT·2011-10-03
K112228 — VITEK 2 STREPTOCOCCUS LEVOFLOXACINbioMerieux, Inc.·Product code LON·2011-10-03
K101273 — DYNAMIC ECG SYSTEM MODEL TLC5000Contec Medical System Co., Ltd.·Product code MLO·2011-09-30
K102673 — RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMPhadia US, Inc.·Product code DHR·2011-09-30
K103327 — DISCOVERY MR750W 3.0TGe Healthcare Japan Corporation·Product code LNH·2011-09-30
K110140 — NEUROVISION NERVE LOCATOR MONITORNeurovision Medical Products, Inc.·Product code GWF·2011-09-30
K110165 — FREERIDER MODEL LUGGIE MODEL 168-4ITFreerider Luggie Scooters, Inc.·Product code INI·2011-09-30
K110327 — LDR SPINE ROI-A INTERBODY FUSION SYSTEMLdr Spine USA·Product code OVD·2011-09-30
K110400 — TAPERLOC COMPLETE MICROPLASTY STEMBiomet Manufacturing Corp·Product code KWA·2011-09-30
K110474 — PHILIPS INTELLIVUE TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN·Product code LKD·2011-09-30
K110846 — RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2Randox Laboratories Limited·Product code JJW·2011-09-30
K110904 — RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3Randox Laboratories, Ltd.·Product code JJY·2011-09-30
K111019 — SURGIMAP (TM) SPINENemaris, Inc.·Product code LLZ·2011-09-30
K111366 — BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEMBecton, Dickinson and Company (BD)·Product code FOZ·2011-09-30
K111412 — SURGISTEER SCISSORS, SURGISTEER DISSECTOR / GRASPER, SURGISTEER HOOKSteerable Technologix·Product code GEI·2011-09-30
K111676 — APEXElekta Limited·Product code IXI·2011-09-30
K111865 — WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATUREFujifilm Medical System U.S.A., Inc.·Product code MQB·2011-09-30
K112096 — IMAGELINKComputer Programs and Systems, Inc.·Product code LLZ·2011-09-30
K112293 — HTS EXTREMITY COIL, HTS SURFACE COILTime Medical Systems, Inc.·Product code MOS·2011-09-30
K112320 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITORHealth & Life Co., Ltd.·Product code DXN·2011-09-30
K112442 — RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEMBiolitec Medical Devices, Inc.·Product code GEX·2011-09-30
K112530 — 3DI INCLUDING CSCOREShina Systems , Ltd.·Product code LLZ·2011-09-30
K112609 — DESARA MESHCaldera Medical, Inc.·Product code OTN·2011-09-30
K112738 — ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWAREAndon Medical Co., Ltd.·Product code NBW·2011-09-30
K110606 — MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLEM.V.S.R.L.·Product code FMI·2011-09-29
K110741 — SCEPTER C OCCLUSION BALLOON CATHETERMicroVention, Inc.·Product code MJN·2011-09-29
K111350 — MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEMMedicam, Inc.·Product code ONF·2011-09-29
K111351 — TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SETUs Infusion Dba Truecare Biomedix·Product code FPA·2011-09-29
K111443 — X12 STERILE REFLECTIVE MARKER SPHEREPinsco Inc. Dba B & L Engineering·Product code OLO·2011-09-29
K111522 — CHARTIS CATHETER MODEL CHR-CA-12.0Pulmonx, Inc.·Product code CBI·2011-09-29
K111570 — MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATORThayer Medical Corporation·Product code CAF·2011-09-29
K111687 — EMG SYSTEMMyotronics-Noromed, Inc.·Product code HCC·2011-09-29
K111816 — EQUIMATRIXLuitpold Pharmaceuticals, Inc.·Product code NPM·2011-09-29
K111832 — PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUIDHeraeus Kulzer, LLC·Product code EBI·2011-09-29
K111878 — PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVESCardinal Health, Inc.·Product code KGO·2011-09-29

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