FDA 510(k) clearances — page 448

176,542 clearances on record, most recent first.

Clearances — page 448

44,701–44,800 of 176,542

K121362 — 1.5T 16CH FLEX SPEEDER LARGENeocoil, LLC·Product code MOS·2012-06-15
K121533 — ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SETTosoh Bioscience, Inc.·Product code LPS·2012-06-15
K111048 — SYNTHES SCOUT TACK FIXATIONSynthes Spine·Product code OMR·2012-06-14
K111136 — EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEMDepuy Spine, Inc.·Product code NKB·2012-06-14
K113008 — KODAMA INTRAVASCULAR ULRASOUND CATHETERSilicon Vally Medical Instruments, Inc.·Product code OBJ·2012-06-14
K113152 — ULTRASONIC SURGERY MACHINEDmetec.Co., Ltd.·Product code DZI·2012-06-14
K113395 — REVERE 4.5 STABILIZATION SYSTEMGlobus Medical, Inc.·Product code NKB·2012-06-14
K113449 — FUSION FLAT PANELIcrco, Inc.·Product code MQB·2012-06-14
K120648 — SYNAPSE 3D LUNG AND ABDOMEN ANALYSISFujifilm Medical System U.S.A., Inc.·Product code LLZ·2012-06-14
K120801 — CHISON DIAGNOSTIC ULTRASOUND SYSTEMChison Medical Imaging Co., Ltd.·Product code IYN·2012-06-14
K121208 — OBIX PERINATAL DATA SYSTEM 7.0Clinical Computer Systems, Inc.·Product code HGM·2012-06-14
K121385 — VECTORR4 Vascular, Inc.·Product code LIT·2012-06-14
K121442 — POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERCordis Corporation·Product code LIT·2012-06-14
K121451 — CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICEMedtronic, Inc.·Product code OCL·2012-06-14
K121470 — FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITORAndon Health Co, Ltd.·Product code DXN·2012-06-14
K121677 — SUREFIRE HI-FLOW MICROCATHETERSurefire Medical, Inc.·Product code DQO·2012-06-14
K111818 — SONIXGPS NEEDLE SENSORUltrasonix Medical Corporation·Product code IYO·2012-06-13
K112897 — RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESISRenovis Surgical Technologies, LLC·Product code OQG·2012-06-13
K120345 — HONOUR SPACER SYSTEMNexxt Spine, LLC·Product code ODP·2012-06-13
K120506 — PARIETEX COMPOSITE VENTRAL PATCHSofradim Production·Product code FTL·2012-06-13
K120546 — AQUILION PREMIUMToshiba Medical Systems Corporation, Japan·Product code JAK·2012-06-13
K120573 — MEDART 620Medart A/S·Product code GEX·2012-06-13
K120658 — DURABLUE STERILIZATION WRAPCardinal Health200, LLC·Product code FRG·2012-06-13
K121051 — CONCIERGE GUIDING CATHETERMerit Medical Systems, Inc.·Product code DQY·2012-06-13
K121129 — SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICESpineology, Inc.·Product code MAX·2012-06-13
K121424 — EXPRESSION INFORMATION PORTALInvivo Corporation·Product code MWI·2012-06-13
K121437 — MINI MAXLOCK EXTREME PLATING SYSTEMOrthohelix Surgical Designs, Inc.·Product code HRS·2012-06-13
K121571 — TUBECLEARActuated Medical, Inc.·Product code KNT·2012-06-13
K113628 — AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIESCatheter Robotics, Inc.·Product code DXX·2012-06-12
K113658 — AMPLATZER VASCULAR PLUG 4Aga Medical Corp.·Product code KRD·2012-06-12
K120045 — EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IVExact Medical Manufacturing, Inc.·Product code FYA·2012-06-12
K120098 — STERILE DISPOSABLES FOR MERAlpha Omega Engineering , Ltd.·Product code GZL·2012-06-12
K120322 — CONMED SUREFIT DUAL DISPERSIVE ELECTRODEConmed Corporation·Product code GEI·2012-06-12
K120476 — MACROLYTE DISPERSIVE ELECTRODEConmed Corporation·Product code GEI·2012-06-12
K120665 — INVENT SNORING DEVICEVentus Medical, Inc.·Product code LWF·2012-06-12
K120695 — DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KITDentist IN A Box Pty., Ltd.·Product code EMB·2012-06-12
K120769 — MODULTH SLKKARL STORZ Endoscopy-America, Inc.·Product code LNS·2012-06-12
K120772 — NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATEZimmer GmbH·Product code HRS·2012-06-12
K120833 — DISCOVERY CT750 HDGe Medical Systems, LLC·Product code JAK·2012-06-12
K121145 — RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARMERenu Medical, Inc.·Product code JOW·2012-06-12
K121249 — MULTIARRAY KITParamed S.R.L.·Product code MOS·2012-06-12
K121328 — AGILITYElekta , Ltd.·Product code IYE·2012-06-12
K121487 — LITECURE THERAPY COMPACTLitecure, LLC·Product code ILY·2012-06-12
DEN080015 — NUCLEUS-X PTV CATHETERNuMED, Inc.·Product code OZT·2012-06-11
K112729 — BLEASE700/900 SERIES VENTILATORSSpacelabs Healthcare·Product code CBK·2012-06-11
K113022 — PURESLEEPSleep Science Partners, Inc.·Product code LRK·2012-06-11
K113205 — ARTISYN Y-SHAPED MESHETHICON, Inc.·Product code OTO·2012-06-11
K113411 — EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULAEdwards Lifesciences, LLC·Product code DWF·2012-06-11
K113868 — EPLUS SKIN TREATMENT SYSTEMSyneron, Ltd.·Product code GEX·2012-06-11
K120174 — DEPUT DELTA XTEND REVERSE SHOULDERDepuy France·Product code PHX·2012-06-11
K120352 — STRYKER QUIKFLAP STERILE PROCEDURE PACKStryker·Product code GWO·2012-06-11
K120494 — DISPOSABLE ADHESIVE SURFACE ELECTRODESpes Medica Srl·Product code GXY·2012-06-11
K121240 — REPROCESSED ENDOSCOPIC TROCARSSterilmed, Inc.·Product code NLM·2012-06-11
K111604 — LANO-EUg Global Resources Sdn. Bhd.·Product code LYY·2012-06-08
K111718 — LANO-EUg Global Resources Sdn. Bhd.·Product code LZA·2012-06-08
K112860 — PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETERColoplast A/S·Product code KNT·2012-06-08
K120164 — PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATUREAngioslide, Ltd.·Product code LIT·2012-06-08
K120214 — TBDLensar, Inc.·Product code OOE·2012-06-08
K120334 — VIVA EBEtview , Ltd.·Product code CBI·2012-06-08
K120432 — TELIO CS CEM IMPLANTIvoclar Vivadent, AG·Product code EMA·2012-06-08
K120465 — EARLYSENSE (EVERON) SYSTEMEarlysense, Ltd.·Product code BZQ·2012-06-08
K120470 — MIPALWatermark Medical·Product code DRG·2012-06-08
K120551 — SIMUPLAN TREATMENT PLANNING SYSTEMSimuplan S.L.·Product code MUJ·2012-06-08
K120624 — ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)Elcam Medical Acal·Product code DRS·2012-06-08
K120752 — AERODR STITCHING SYSTEMKonica Minolta Medical & Graphic, Inc.·Product code KPR·2012-06-08
K120784 — TUFF-TEMP 2.0Pulpdent Corporation·Product code EBG·2012-06-08
K120790 — GMK - LINE EXTENSIONMedacta International·Product code JWH·2012-06-08
K120820 — GIRAFFE BLUE SPOT PT LITELumitex, Inc.·Product code LBI·2012-06-08
K120846 — TRANSPORT CULTURE MEDIUM DEVICEPuritan Medical Products, LLC·Product code LIO·2012-06-08
K121011 — AMISTEM AND QUADRA - LINE EXTENSIONMedacta International·Product code LZO·2012-06-08
K121074 — SCENIUM 2.0Siemens Medical Solutions USA, Inc.·Product code LLZ·2012-06-08
K121402 — CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' GTrireme Medical, Inc.·Product code LIT·2012-06-08
K121412 — PAX-FLEX3D, PHT-7000VATECH Co., Ltd.·Product code OAS·2012-06-08
K121545 — BELLYBOARD, SBRT ACCESSORIESMedtec Inc. Dba Civco Medical Solutions·Product code LNH·2012-06-08
K121554 — Q-FLO CLOSED MALE LUER CONNECTORUs Fusion, LLC. Dba Truecare Biomedix-USA·Product code FPA·2012-06-08
K112090 — BAHADIR STERILIZATION TRAYSBahadir USA Corp.·Product code KCT·2012-06-07
K112607 — SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ...Spinevision S.A.·Product code NKB·2012-06-07
K120646 — CAPSURE(R) PS SYSTEMSpine Wave, Inc.·Product code MNI·2012-06-07
K120808 — EXPORT XT CATHETER, EXPORT AP CATHETERMedtronic, Inc.·Product code QEZ·2012-06-07
K120841 — APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHORKfx Medical·Product code MBI·2012-06-07
K120871 — SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.·Product code JDW·2012-06-07
K121381 — VIEWFLEX XTRA ICE CATHETERSt Jude Medical·Product code IYO·2012-06-07
K121444 — FLAT PANEL DETECTORCanon, Inc. - Medical Equpment Group·Product code OWB·2012-06-07
K112627 — MILLENIUM ANTI-SNORING DEVICEMillenium Dental Laboratory, Inc.·Product code LQZ·2012-06-06
K113363 — ANGIOJET SOLENT DISTA THROMBECTOMY SETMedrad, Inc.·Product code QEZ·2012-06-06
K113785 — ADHERENT VISUAL STIMULATOR GOGGLESAnschel Technology, Inc.·Product code GWE·2012-06-06
K120198 — LOCATOR OVERDENTURE IMPLANT SYSTEMZest Anchors, LLC·Product code DZE·2012-06-06
K120220 — ADAPTAIN SOLUBLE IMPLANT MATERIALCeremed , Inc.·Product code KHJ·2012-06-06
K120552 — AIR LIFT/XEROSTOM ARTIFICIAL SALIVABiocosmetics Laboratories·Product code LFD·2012-06-06
K120712 — FORA COMFORTSCAN EAR THERMOMETERTaidoc Technology Corporation·Product code FLL·2012-06-06
K120731 — TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRYVarian Medical Systems, Inc.·Product code JAQ·2012-06-06
K120852 — ZIRCONIA BLANKS (ZIRCOSTAR)Kerox, Ltd.·Product code EIH·2012-06-06
K120987 — DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFFMedtronic, Inc.·Product code DWF·2012-06-06
K121064 — MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMMako Surgical Corporation·Product code OLO·2012-06-06
K121094 — MEDCOMP VASCU-PICC & MIDLINE CATHETERSMedical Components, Inc.·Product code LJS·2012-06-06
K121128 — MULTIPURPOSE HANDLING MEDIUMIrvine Scientific Sales Co., Inc.·Product code MQL·2012-06-06
K121131 — BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MMStraumann USA·Product code DZE·2012-06-06
K121318 — PROSOFTPerma Laboratories·Product code EBP·2012-06-06
K121480 — ARIATELE TELEMETRY TRANSMITTER (96281)Spacelabs Healthcare·Product code MHX·2012-06-06
K121507 — ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)AtriCure, Inc.·Product code GEH·2012-06-06

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