FDA 510(k) clearances — page 491

176,542 clearances on record, most recent first.

Clearances — page 491

49,001–49,100 of 176,542

K103190 — PROFIL COMPOSITES (PROFIL, PROFIL FLOW)Silmet , Ltd.·Product code EBF·2011-02-02
K103213 — FINESS ENDOSCOPE STERILIZATION TRAYEntellus Medical, Inc.·Product code KCT·2011-02-02
K103347 — CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESESIntervascular Sas·Product code DSY·2011-02-02
K103385 — SECURVIEW DX DIAGNOSTIC WORKSTATIONHologic, Inc.·Product code LLZ·2011-02-02
K103387 — MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROLACON Laboratories, Inc.·Product code JJW·2011-02-02
K103393 — POLARIS SPINAL SYSTEMBiomet Spine·Product code KWQ·2011-02-02
K103506 — 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)Imris, Inc.·Product code MOS·2011-02-02
K103629 — PET-512MC TRANSESOPHAGEAL TRANSDUCERToshiba America Medical Systems, In.C·Product code ITX·2011-02-02
K110009 — ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDECook, Inc.·Product code DQX·2011-02-02
K102238 — ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETERTeleflexmedical, Inc.·Product code MSD·2011-02-01
K103056 — VISULAS TRION LASER SYSTEM WITH THE VITE OPTIONCarl Zeiss Meditec, AG·Product code HQF·2011-02-01
K102369 — PICCOLO COMPOSITE NAILING SYSTEMN.M.B. Medical Applications, Ltd.·Product code HSB·2011-01-31
K102924 — AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEMTornier, Inc.·Product code KWS·2011-01-31
K103208 — REVERSE SHOULDER PROSTHESIS MONOBLOCK STEMEncore Medical L.P.·Product code PHX·2011-01-31
K103254 — PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBEColoplast A/S·Product code KNT·2011-01-31
K103256 — SMITH & NEPHEW SMF HIP STEMSmith & Nephew, Inc.·Product code LPH·2011-01-31
K103288 — DEKA SYNCHRO FTEl.En Electronic Engineering Spa·Product code GEX·2011-01-31
K103465 — SYNAPSE 3D CARDIAC TOOLSFujifilm Medical Systems U.S.A, Inc.·Product code LLZ·2011-01-31
K103677 — M7/M7T DIAGNOSTIC ULTRASOUND SYSTEMShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYN·2011-01-31
K110071 — COR ANALYZERRcadia Medical Imaging , Ltd.·Product code LLZ·2011-01-31
K101016 — ANS SYSTEMCaird Technology·Product code DPS·2011-01-28
K101136 — FISIO CHAMBER SPACEKoo (Shanghai) Industries Co., Ltd.·Product code NVP·2011-01-28
K101263 — LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,Lima-Lto S.P.A.·Product code KWT·2011-01-28
K101454 — MAMMAPRINTAgendia·Product code NYI·2011-01-28
K102319 — COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008Won Industrial Co.·Product code IRP·2011-01-28
K102621 — SOLSTICEKerr Corporation·Product code EBZ·2011-01-28
K102664 — HEMA SCREEN ERImmunostics Inc.,·Product code KHE·2011-01-28
K102824 — AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRICAmbu A/S·Product code BTM·2011-01-28
K102884 — STERRAD CYCLESURE 24 BIOLOGICAL INDICATORAdvanced Sterilization Products·Product code FRC·2011-01-28
K103009 — SENTICARE PILLSTATIONSenticare, Inc.·Product code NXQ·2011-01-28
K103014 — MIRADRY SYSTEMMiramar Labs, Inc.·Product code OUB·2011-01-28
K110077 — NEUCOLONCARENeusoft Medical Systems Co., Ltd.·Product code LLZ·2011-01-28
K092025 — FLUID FILLED TEETHER - GELKids II·Product code KKO·2011-01-27
K093617 — VENTLAB 6000 SERIES HUMIDIFIERVentlab Corp.·Product code BTT·2011-01-27
K101346 — GC ORAL MOISTURIZING GELGC America, Inc.·Product code LFD·2011-01-27
K101459 — OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770Smith & Nephew, Inc.·Product code MAI·2011-01-27
K102363 — SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004Spsmedical Supply Corp.·Product code JOJ·2011-01-27
K102722 — NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTYSynthes USA Products, LLC·Product code MQV·2011-01-27
K103297 — REDONDO-LSeaspine, Inc.·Product code MAX·2011-01-27
K103782 — 4D MV-ASSESSMENT 2.0Tomtec Imaging Systems GmbH·Product code DQK·2011-01-27
K101628 — KOWA NONMYD WXKowa Co. , Ltd.·Product code HKI·2011-01-26
K101643 — MODEL LTV 1100 VENTILATORCare Fusion·Product code CBK·2011-01-26
K101807 — STAYHEALTHY BODY COMPOSITION MONITOR-BCMStayhealthy, Inc.·Product code MNW·2011-01-26
K101945 — NEODENT IMPLANT SYSTEMJjgc Industria E Comercio DE Materiais Dentarios S·Product code DZE·2011-01-26
K102101 — SURGIVISION MR COMPATIBLE VENTRICULAR CANNULASurgivision, Inc.·Product code HCD·2011-01-26
K102792 — DISPOSABLE BLOOD PRESSURE CUFCaremate Medical Device Co., Ltd.·Product code DXQ·2011-01-26
K102886 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek, Inc.·Product code KWP·2011-01-26
K102927 — CONSENSUS KNEE SYSTEMConsensus Orthopedics, Inc.·Product code MBH·2011-01-26
K103176 — FREQUENCERDymedso, Inc.·Product code BYI·2011-01-26
K103187 — TRIPLEPLAY-VT VASCULAR THERAPY SYSTEMWildcat Medical, Inc.·Product code JOW·2011-01-26
K103305 — PENUMBRA EMBOLIZATION COIL SYSTEMPenumbra, Inc.·Product code HCG·2011-01-26
K103522 — SEDECALSedecal., Sa.·Product code IZL·2011-01-26
K103778 — LEFORTE NEURO SYSTEM BONE PLATEJeil Medical Corporation·Product code JEY·2011-01-26
K103780 — MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIOMicrus Endovascular Corporation·Product code MJN·2011-01-26
K103800 — BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERSKaz USA, Inc (A Subsidiaryof Kaz Inc)·Product code FLL·2011-01-26
K110004 — ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICEAdvanced Surgical Concepts·Product code OTJ·2011-01-26
K110040 — OMNIVISIONModern Module, Inc.·Product code LLZ·2011-01-26
K110048 — CERSR ELECTROMYOGRAPHY SYSTEMSpinematrix, Inc.·Product code IKN·2011-01-26
K110085 — VANTAGE VIEW SYSTEMSt Jude Medical·Product code DXJ·2011-01-26
K090145 — SURECALL EMG LABOR MONITORReproductive Research Technologies, LP·Product code OSP·2011-01-25
K093989 — ORAL FLUID PHENCYCLIDINERoche Diagnostics·Product code LCM·2011-01-25
K100794 — FLUORCANASITE DENTAL CERAMICDr Sarah Pollington·Product code EIH·2011-01-25
K100875 — CEROX, MODEL 321OFOr-Nim Medical , Ltd.·Product code MUD·2011-01-25
K101171 — ORTHOVITA PEEK SPACEROrthovita, Inc.·Product code ODP·2011-01-25
K101225 — PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1Promimic AB·Product code DZE·2011-01-25
K101741 — DIATRON PICTUS 400Diatron Group·Product code CGA·2011-01-25
K102561 — ORTHODONTIC CERAMIC BRACKETHt Co., Ltd.·Product code NJM·2011-01-25
K102713 — TIGER FLAT SURGICAL MASKTiger Medical Products, Ltd.·Product code FXX·2011-01-25
K102853 — FLAMENCO SPINAL FIXATION SYSTEMUlrich GmbH & Co. KG·Product code MNH·2011-01-25
K103166 — CHEETAH RELIANTCheetah Medical, Inc.·Product code DSB·2011-01-25
K103271 — MSC LIPID CONTROLMaine Standards Co.·Product code JJY·2011-01-25
K103450 — FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLEFujirebio Diagnostics,Inc.·Product code JJX·2011-01-25
K103511 — LITECURE THERAPY SYSTEMLitecure, LLC·Product code ILY·2011-01-25
K103612 — DIMENSION VISA ENZ 2 CALSiemens Healthcare Diagnostics, Inc.·Product code JIX·2011-01-25
K103616 — PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZERAktina Medical Physics Corp.·Product code IYE·2011-01-25
K103805 — MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICEMedical Wire & Equipment Company (Bath), Ltd.·Product code LIO·2011-01-25
K103815 — Q-STATIONPhilips Ultrasound, Inc.·Product code LLZ·2011-01-25
K100591 — SORBACTAbigo Medical AB·Product code FRO·2011-01-24
K100823 — WOUND PRO APEXAccuro Medical Products, LLC·Product code OMP·2011-01-24
K101604 — VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274VVascular Solutions, Inc.·Product code DYB·2011-01-24
K102123 — VIZION DRViztek, Inc.·Product code KPR·2011-01-24
K102218 — COMPACT PIEZO P2K, POWERCAREMectron S.P.A.·Product code ELC·2011-01-24
K102336 — RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NEBoston Scientific Corporation·Product code BWH·2011-01-24
K102670 — TOTAL SHOULDER SYSTEMShoulder Innovations, LLC·Product code KWS·2011-01-24
K103157 — DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLEAngstrom Mfg., Inc.·Product code EGS·2011-01-24
K103231 — KYPHON INFLATION SYRINGEMedtronic Spine, LLC·Product code HRX·2011-01-24
K103332 — APTUS ULNA PLATESMedartis AG·Product code HRS·2011-01-24
K090626 — ENDOSERTEROcular Systems, Inc.·Product code OTZ·2011-01-21
K090754 — LIPOCONTROLOsyris Medical·Product code ORK·2011-01-21
K093101 — MAGO 4SDiamedix Corp.·Product code LFX·2011-01-21
K100625 — REALEYE MODEL VCPSNavotek Medical, Ltd.·Product code IYE·2011-01-21
K100957 — DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATIONPacific Consolidated Industries, LLC·Product code CAW·2011-01-21
K101147 — MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMAlma Lasers, Inc.·Product code NUV·2011-01-21
K101354 — FETCH 2 ASPIRATION CATHETER MODEL 109400-001Medrad Interventional/Possis·Product code QEZ·2011-01-21
K101894 — HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNITBioremedi Therapeutic Systems, Inc.·Product code ILY·2011-01-21
K102154 — TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSThe Lagado Corp.·Product code HQD·2011-01-21
K102227 — INFA WARMER IAtom Medical Corporation·Product code FMT·2011-01-21
K102775 — HAMILTON-C2Hamilton Medical AG·Product code CBK·2011-01-21
K102870 — EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEMExactech, Inc.·Product code MNH·2011-01-21
K103141 — LOW ADHERENT AFM AG DRESSINGSMilliken Healthcare Products, LLC·Product code FRO·2011-01-21

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