FDA 510(k) clearances — page 480

176,542 clearances on record, most recent first.

Clearances — page 480

47,901–48,000 of 176,542

K110640 — ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENTAstra Tech, Inc.·Product code NHA·2011-06-10
K110759 — TEMPOCEMDmg USA, Inc.·Product code EMB·2011-06-10
K110936 — DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KITAngioDynamics, Inc.·Product code MSD·2011-06-10
K110969 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Ppp Medical and Safety Products Company Limited·Product code LYZ·2011-06-10
K111023 — ABBOTT ARCHITECT LH CALIBRATORSAbbott Laboratories·Product code JIT·2011-06-10
K111344 — I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)Infimed, Inc.·Product code OWB·2011-06-10
K111471 — EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)Medshape Solutions, Inc.·Product code MBI·2011-06-10
K102496 — POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUSCardiac Science Corporation·Product code MKJ·2011-06-09
K103019 — KJ MASKKj Meditech Co., Ltd.·Product code DZB·2011-06-09
K110273 — AEROVENT PLUS CHCMonaghan Medical Corporation·Product code CAF·2011-06-09
K110394 — ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)Vital Diagnostics (Manufacturing) Ptyltd·Product code JIX·2011-06-09
K110850 — K-PACK II NEEDLE- 27G & 30G THIN WALLTerumo Europe N.V.·Product code FMI·2011-06-09
K111016 — SAFEPORT MANIFOLD (TM) (OR STOPCOCK)Elcam Medical Acal·Product code FPA·2011-06-09
K111020 — ATRICURE DISSECTORAtriCure, Inc.·Product code FTD·2011-06-09
K111092 — ENGAGE/ENGAGE TR INTRODUCERSSt Jude Medical·Product code DYB·2011-06-09
K111349 — ELECSYS SHBG CALCHECK 5Roche Diagnostics·Product code JJX·2011-06-09
K103429 — BIOGRAPH MMRSiemens Medical Solutions USA, Inc.·Product code OUO·2011-06-08
K103637 — ERKA. PERFECT-ANEROIDErka Kallmeyer Medizintechnik GmbH·Product code DXQ·2011-06-08
K103724 — 10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030)Eizo GmbH·Product code LLZ·2011-06-08
K110070 — TSRH SPINAL SYSTEMMedtronic Sofamor Danck USA, Inc.·Product code NKB·2011-06-08
K110272 — STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGCardinal Health, Inc.·Product code KGO·2011-06-08
K110284 — NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEMMedyssey Co, Ltd.·Product code MNI·2011-06-08
K110693 — PACEART OPTIMA SYSTEM SOFTWAREMedtronic, Inc.·Product code KRE·2011-06-08
K110728 — IMESH TACKEREasylap , Ltd.·Product code GDW·2011-06-08
K110883 — J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULABusse Hospital Disposables·Product code KNW·2011-06-08
K111007 — MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORSMidwest Reprocessing Center, LLC·Product code NMD·2011-06-08
K111111 — ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELOEthicon Endo-Surgery, LLC·Product code GDW·2011-06-08
K111315 — MULTIPURPOSE DRAINAGE CATHETERNavilyst Medical, Inc.·Product code FGE·2011-06-08
K111339 — HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)Medtronic, Inc.·Product code JOX·2011-06-08
K111379 — EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHTExactech, Inc.·Product code KWS·2011-06-08
K103086 — DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRICDynarex Corporation·Product code EZD·2011-06-07
K110158 — ILLUMINATING SINUS SEEKEREntellus Medical, Inc.·Product code LRC·2011-06-07
K101733 — REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIESSac, LLC Dba Pinnacle Medical Surgical·Product code GCJ·2011-06-06
K102623 — BLUE POWDERFREE NITRILE EXAMINATION GLOVEPt. Medisafe Technologies·Product code LZA·2011-06-06
K103210 — TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORSAdvanced Sterilization Products·Product code FRG·2011-06-06
K103839 — BEHIND EAR GENTLE TOUCH THERMOMETERKaz, Inc.·Product code FLL·2011-06-06
K110405 — TRUBLUE NASAL MASKRespironics, Inc.·Product code BZD·2011-06-06
K110527 — K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USETerumo Europe N.V.·Product code FMI·2011-06-06
K110753 — MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEMDentsply International, Inc.·Product code EKX·2011-06-06
K110972 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLORPpp Medical and Safety Products Company Limited·Product code LYZ·2011-06-06
K111017 — CLEARTEMPUltradent Products, Inc.·Product code EMA·2011-06-06
K111041 — MINI VARIABLE SYSTEMOrthohelix Surgical Designs, Inc.·Product code HRS·2011-06-06
K101627 — IPLANBrainlab AG·Product code HAW·2011-06-03
K102566 — OWL CANNULAEDiros Technology, Inc.·Product code GXI·2011-06-03
K102614 — AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40Bio-Medical Research, Ltd.·Product code GXY·2011-06-03
K102767 — CARDIO XPBionet Co., Ltd.·Product code DPS·2011-06-03
K103266 — ISTANDOptovue, Inc.·Product code HLI·2011-06-03
K110275 — ORTHO EASY PINForestadent Bernhard Forster GmbH·Product code OAT·2011-06-03
K110508 — SUGLUE-103M Espe AG·Product code EMA·2011-06-03
K110645 — BIO Z CARDIO PROFILE HEMODYNAMIC MONITORSonosite,Inc.·Product code DSB·2011-06-03
K110732 — EMULSION SBPrugen IP Holdings, Inc.·Product code FRO·2011-06-03
K110769 — AMSCO WARMING CABINETSTERIS Corporation·Product code LGZ·2011-06-03
K110829 — ACE STAPLER AND CARTRIDGEBarosense, Inc.·Product code OCW·2011-06-03
K111093 — BILLY BOY MALE LATEX CONDOMMapa GmbH·Product code HIS·2011-06-03
K111292 — LUMINOS AGILESiemens Medical Solutions USA, Inc.·Product code JAA·2011-06-03
K111442 — V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...Covidien, Formerly US Surgical A Divison of Tyco H·Product code GAM·2011-06-03
K111445 — DISCOVERY NM 630GE Healthcare·Product code KPS·2011-06-03
K100943 — INVADER FACTOR IIHologic, Inc.·Product code NPR·2011-06-02
K102461 — FRACTORAInvasix , Ltd.·Product code GEI·2011-06-02
K102479 — ALARA T210 COMPUTED RADIOGRAPHY SYSTEMAlara, Inc.·Product code MQB·2011-06-02
K102490 — IGX PLEX CELIAC QUALITATIVE ASSAYSqi Diagnostics Systems·Product code MVM·2011-06-02
K102567 — WATCH-PAT 200S-3 (WP200S-3)Itamar Medical , Ltd.·Product code MNR·2011-06-02
K102811 — AOS ORION IR-192 SOURCE CABLEAlpha-Omega Services, Inc.·Product code KXK·2011-06-02
K103205 — BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEMAlphatec Spine, Inc.·Product code KWP·2011-06-02
K103548 — ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491Siemens Healthcare Diagnostics, Inc.·Product code JIT·2011-06-02
K103578 — PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSISTRespironics Novametrix, LLC·Product code BZK·2011-06-02
K103703 — REGUIS SIGMAKonica Minolta Medical & Graphic, Inc.·Product code MQB·2011-06-02
K103737 — OMNI II PATIENT MONITORInfinium Medical·Product code MWI·2011-06-02
K110143 — HET BIPOLAR ELECTROCAUTERY FORCEPSHet Systems, LLC·Product code GEI·2011-06-02
K110617 — MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETERAbbott Vascular·Product code LOX·2011-06-02
K110658 — APTUS CANNULATED COMPRESSION SCREWSMedartis AG·Product code HWC·2011-06-02
K110669 — TAMPAX C PLASTIC TAMPONS, UNSCENTEDThe Procter & Gamble Co.·Product code HEB·2011-06-02
K110688 — MYLABGOLDEsaote·Product code IYO·2011-06-02
K110773 — TORNIER INSITE FT SUTURE ANCHORTornier, Inc.·Product code MBI·2011-06-02
K111252 — ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8FBoston Scientific Corp·Product code DQY·2011-06-02
K100980 — INVADER FACTOR VHologic, Inc.·Product code NPQ·2011-06-01
K103023 — UNIT, PHACOFRAGMENTATIONAbbott Medical Optics, Inc.·Product code HQC·2011-06-01
K103423 — MIS ANTERIOR CERVICAL PLATING SYSTEMLife Spine·Product code KWQ·2011-06-01
K103738 — H-WAVEElectronic Waveform Laboratory, Inc.·Product code IPF·2011-06-01
K110398 — RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITSRespironics, Inc.·Product code BZE·2011-06-01
K110516 — CONNEX VITAL SIGNS MONITOR 6000 SERIESWelch Allyn, Inc.·Product code MWI·2011-06-01
K111229 — JETSTREAM G3 (R) SF 1.6 SYSTEMPathway Medical Technologies, Inc.·Product code MCW·2011-06-01
K110268 — FORCETRIAD ELECTROSURGICAL GENERATORCovidien Lp, Formerly Know AS Valleylab, A Divison·Product code GEI·2011-05-31
K110957 — M4 MONITORSpectrum Medical, Llp·Product code DRY·2011-05-31
K111295 — .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERSBoston Scientific Corporation·Product code LIT·2011-05-31
K092338 — MEDAX UNIPERSONALE SRLMedax Unipersonale Srl·Product code KNW·2011-05-27
K100895 — PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30)Dipped Products Limited·Product code LYY·2011-05-27
K101251 — IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGENPhadia AB·Product code DHB·2011-05-27
K101681 — TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995Zhongshan Transtek Electronics Co., Ltd.·Product code DXN·2011-05-27
K101952 — KONIX ULTRASOUND GELTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa·Product code ITX·2011-05-27
K102049 — CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation·Product code NBW·2011-05-27
K102935 — INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818AKingtech Enterprise, Ltd.·Product code FLL·2011-05-27
K103775 — PEAK SUCTION COAGULATORPeak Surgical, Inc.·Product code GEI·2011-05-27
K110097 — ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPEAcclarent, Inc.·Product code EOB·2011-05-27
K110214 — DIRECTVISION CATHETER, UNCOATEDPercuvision·Product code EZL·2011-05-27
K110226 — INTERFUSE T INVERTEBRAL BODY FUSION DEVICEVertebral Technologies, Inc.·Product code MAX·2011-05-27
K110233 — HAIRMAX LASERCOMBLexington International, LLC·Product code OAP·2011-05-27
K110256 — THE IC-PRO SYSTEMPaieon, Inc.·Product code IZI·2011-05-27
K110447 — ECHOINSIGHTUltrasound Medical Devices, Inc.·Product code LLZ·2011-05-27
K110589 — CIMARAVoco GmbH·Product code EBF·2011-05-27

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