FDA 510(k) clearances — page 464

176,542 clearances on record, most recent first.

Clearances — page 464

46,301–46,400 of 176,542

K113068 — REMSTAR AUTO A-FLEX HTRespironics, Inc.·Product code BZD·2011-12-16
K113121 — COMPREHENSIVE REVERSE SHOULDERBiomet Manufacturing, Inc.·Product code PHX·2011-12-16
K113193 — PATIENT EXAMINATION GLOVESuqian Ruijang Medical Supplies Co., Ltd.·Product code LYZ·2011-12-16
K113270 — INSTINCT JAVA SYSTEMZimmer Spine·Product code NKB·2011-12-16
K113400 — FIXATE TISSUE BANDAnulex Technologies, Inc.·Product code GZB·2011-12-16
K113457 — HYDROCOIL EMBOLIC SYSTEM (HES)MicroVention, Inc.·Product code HCG·2011-12-16
K113476 — ANSPACH DISSECTION TOOLSThe Anspach Effort, Inc.·Product code HBE·2011-12-16
K113541 — CLEARSTART SVM SYSTEMIntio, Inc.·Product code LLZ·2011-12-16
K113543 — ONDEMAND3DCybermed, Inc.·Product code LLZ·2011-12-16
K113647 — DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEMShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYN·2011-12-16
K102456 — INTRAORAL BELSENSOR GOLDTakara Belmont USA, Inc.·Product code MUH·2011-12-15
K102898 — BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONEPanpac Medical Corporation·Product code LKF·2011-12-15
K110633 — LANCER PEDICLE SCREW SYSTEMSpinal Solutions, LLC·Product code MNH·2011-12-15
K111170 — PICOSmith & Nephew, Inc.·Product code OMP·2011-12-15
K111669 — FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMSInsulet Corporation·Product code LZG·2011-12-15
K111746 — COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)Biomet, Inc.·Product code KWT·2011-12-15
K112040 — ARTHREX BIOCOMPOSITE TRANSFIXArthrex, Inc.·Product code MAI·2011-12-15
K112218 — ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORSDePuy Orthopaedics, Inc.·Product code KTT·2011-12-15
K112275 — FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation·Product code NBW·2011-12-15
K112490 — QUIDEL MOLECULAR HMPV ASSAYQuidel Corp.·Product code OEM·2011-12-15
K112560 — APTUS(R) DISTAL HUMERUS SYSTEMMedartis AG·Product code HRS·2011-12-15
K112562 — BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETERKimberly-Clark·Product code OYI·2011-12-15
K112780 — CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.·Product code JWH·2011-12-15
K112876 — CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5Cayenne Medical, Inc.·Product code MBI·2011-12-15
K113105 — TEMPUSIC PATIENT MONITORRemote Diagnostic Technologies , Ltd.·Product code MWI·2011-12-15
K113107 — MSA HIP SYSTEMGlobal Manufacturing Technology·Product code MEH·2011-12-15
K113133 — MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGEMedrad, Inc.·Product code DXT·2011-12-15
K113299 — ROG SUTURE ANCHORRog Sports Medicine, Inc.·Product code MBI·2011-12-15
K113564 — EXSALT T7 WOUND DRESSINGExciton Technologies, Inc.·Product code FRO·2011-12-15
K110392 — PSM LOMAS / BENEFIT SCREWSPsm Medical Solutions·Product code OAT·2011-12-14
K111313 — EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVEAlcavis Hdc, LLC·Product code FQH·2011-12-14
K111738 — CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)Trireme Medical, Inc.·Product code DQY·2011-12-14
K111753 — HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDEHitachi Chemical Diagnostics, Inc.·Product code CHH·2011-12-14
K112057 — KDL SYRINGES AND NEEDLEShanghai Kindly Enterprise Dev. Group Co.,·Product code FMF·2011-12-14
K112160 — TAPERED SCREW-VENT X IMPLANTZimmer Dental, Inc.·Product code DZE·2011-12-14
K112203 — COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSISTMirador Biomedical, Inc.·Product code DRS·2011-12-14
K112316 — 4-WEB ALIF SPINAL TRUSS SYSTEM (STS)4-Web, Inc.·Product code MAX·2011-12-14
K112382 — TERUMO ASPRIATION CATHETERTerumo Medical Corporation·Product code QEZ·2011-12-14
K112402 — ULTRAMAXO2 OXYGEN ANALYERMaxtec, LLC·Product code CCL·2011-12-14
K112501 — VENUS PEARL PLT REFILL A1Heraeus Kulzer, LLC·Product code EBF·2011-12-14
K112683 — SMI CARDIOVASCULAR PACHSolimas Medical, Inc.·Product code DXZ·2011-12-14
DEN100002 — INFRASCANNER, MODEL 1000Infrascan, Inc.·Product code OPT·2011-12-13
K102909 — SOMNOBRUX SPLINTSSomnomed, Inc.·Product code MQC·2011-12-13
K103161 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATESOmega Laboratories, Inc.·Product code DJG·2011-12-13
K110604 — VBB SYSTEMSynthes·Product code NDN·2011-12-13
K111168 — PRECISION SKIN EMULSIONPrecision Dermatology Incorporated·Product code FRO·2011-12-13
K111418 — STAXX(R) XD SYSTEMSpine Wave, Inc.·Product code MQP·2011-12-13
K112480 — VIEW 1 IMAGINGKarl Storz Endoscopy America, Inc.·Product code LLZ·2011-12-13
K112672 — HEADLESS COMPRESSION SCREWSkeletal Dynamics, LLC·Product code HWC·2011-12-13
K112857 — INTERFACE BONE VOID FILLERBiostructures, LLC·Product code MQV·2011-12-13
K113034 — GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEMGE Healthcare·Product code IZI·2011-12-13
K113079 — SYNTHES HEMOSTATIC BONE PUTTYSynthes (Usa) Products, LLC/Norian Corporation·Product code MTJ·2011-12-13
K113348 — COUGAR SYSTEMJohnson & Johnson·Product code MAX·2011-12-13
K113412 — TARGET DETACHABLE COILStryker Neurovascular·Product code HCG·2011-12-13
K102425 — ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEMZeus Scientific, Inc.·Product code MID·2011-12-12
K111995 — XINGTM SPINE SYSTEMImplanova Co., Ltd.·Product code MNH·2011-12-12
K112459 — SYNTHES ZERO-PSynthes Spine Co.Lp·Product code OVE·2011-12-12
K112658 — OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEMOsteospring Medical, Inc.·Product code HWC·2011-12-12
K112675 — ARROW-LOK DIGITAL SYSTEMArrowhead Medical Device Technologies, LLC·Product code HTY·2011-12-12
K112983 — SPACER-STecres S.P.A.·Product code HSD·2011-12-12
K113102 — ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNINGNucletron·Product code MUJ·2011-12-12
K113181 — CELLTRACKS ANALYER IIVeridex, LLC·Product code NQI·2011-12-12
K113339 — ORTHOLOC 3DSI LOCKING SCREWSWrightmedicaltechnologyinc·Product code HRS·2011-12-12
K113465 — ACCULIF TL CAGECoalign Innovations, Inc.·Product code MAX·2011-12-12
K102494 — THE BUZZ FACIAL TONING SYSTEMDaka International , Ltd.·Product code NFO·2011-12-09
K111132 — GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEMGenesys Spine·Product code KWQ·2011-12-09
K111452 — PRESAGE ST2 ASSAYCritical Care Diagnostics, Inc. (Dba Critical Diag·Product code OYG·2011-12-09
K111826 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORAndon Health Co, Ltd.·Product code DXN·2011-12-09
K111830 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MOAndon Health Co, Ltd.·Product code DXN·2011-12-09
K112028 — SI-LOK SACROILIAC JOINT FIXATION SYSTEMGlobus Medical, Inc.·Product code HWC·2011-12-09
K112229 — SARN CENTRIFUGAL PUMPTerumo Cardiovascular Systems·Product code KFM·2011-12-09
K112513 — EBONY PTA 0.014 PERIPHERAL DILATATION CATHETERNatec Medical , Ltd.·Product code LIT·2011-12-09
K112637 — NETKONNECT REMOTE NETWORK EXTENSIONNihon Kohden·Product code MHX·2011-12-09
K112946 — ACTIV VARNISHPulpdent Corporation·Product code LBH·2011-12-09
K113084 — RENOVIS CANNULATED SCREW SYSTEMRenovis Surgical Technologies, LLC·Product code HWC·2011-12-09
K113300 — ATB ADVANCE PTA DILATATION CATHETERCook, Inc.·Product code LIT·2011-12-09
K113303 — OSLEOBRIDGE IDSF SPACER CONECTORMerete Medical GmbH·Product code HSB·2011-12-09
K113325 — EVOLUTION MP ADAPTIVE CS INSERTWrightmedicaltechnologyinc·Product code JWH·2011-12-09
K113500 — CANADY VIEIRA HYBRID PLASMA SCALPELUs Medical Innovations, LLC·Product code GEI·2011-12-09
K093477 — SHIELD KYPHOPLASTY SYSTEMSoteira, Inc.·Product code NDN·2011-12-08
K103103 — PRESSON ELECTRODEPersyst Development Corp.·Product code GXZ·2011-12-08
K110068 — MODEL PM3030Omron Healthcare, Inc.·Product code NUH·2011-12-08
K110325 — AQUA LUBEMayer Laboratories, Inc.·Product code NUC·2011-12-08
K110379 — AIR-N-GOSatelec·Product code EFB·2011-12-08
K110926 — BONE PLATE; BONE SCREWBiomaterials Korea, Inc.·Product code JEY·2011-12-08
K111123 — VARILIFT CERVICAL INTERBODY FUSION SYSTEMWenzel Spine·Product code ODP·2011-12-08
K111310 — BRUX MOUTHGUARDSDental Arte, Inc.·Product code OBR·2011-12-08
K111646 — ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCRFujifilm Medical System U.S.A., Inc.·Product code MUE·2011-12-08
K111651 — SPLIT CATH IIIMedical Components, Inc.·Product code MSD·2011-12-08
K111736 — TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVESTuttnauer Co. , Ltd.·Product code FLE·2011-12-08
K111853 — ANGLED TAPERED ABUTMENTZimmer Dental, Inc.·Product code NHA·2011-12-08
K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTERKeeler Instruments, Inc.·Product code HRN·2011-12-08
K112208 — INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIESIntuitive Surgical, Inc.·Product code NAY·2011-12-08
K112533 — ZAVATION CERVICAL PLATE SYSTEMZavation, LLC·Product code KWQ·2011-12-08
K112991 — MODIFIED ROG SUTURE ANCHORRog Sports Medicine, Inc.·Product code MBI·2011-12-08
K113111 — CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTIONInovo, Inc.·Product code NFB·2011-12-08
K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTERBaxter Healthcare Corp·Product code FPB·2011-12-08
K113309 — EXACTECH EQUINOXE CAGE GLENOIDSExactech, Inc.·Product code KWS·2011-12-08
K103544 — IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV DAgamatrix, Inc.·Product code NBW·2011-12-07
K110046 — ATHENA PEDICLE SCREW SYSTEMRoyal Oak Medical Devices·Product code NKB·2011-12-07

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