FDA 510(k) clearances — page 463

176,542 clearances on record, most recent first.

Clearances — page 463

46,201–46,300 of 176,542

K111204 — CELL-DYN 22 PLUS CALIBRATORStreck·Product code KRX·2011-12-22
K111211 — CELL-DYN 22 PLUS CONTROLStreck·Product code GLQ·2011-12-22
K111324 — CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZERAgfa Healthcare N.V.·Product code MUE·2011-12-22
K111617 — PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1Acare Technology Co., Ltd.·Product code DQA·2011-12-22
K111919 — IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTSPhadia US, Inc.·Product code DHB·2011-12-22
K112041 — KOO SMALL VOLUME NEBULIZER (SVN)Koo (Shanghai) Industries Co., Ltd.·Product code CAF·2011-12-22
K112109 — THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICEOrtho Kinematics, Inc.·Product code LLZ·2011-12-22
K112172 — QUIDEL MOLECULAR INFLUENZA A + B ASSAYQuidel Corp.·Product code OCC·2011-12-22
K112216 — U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEMTaidoc Technology Corporation·Product code DXN·2011-12-22
K112423 — COLLAGEN TENDON SHEETRotation Medical, Inc.·Product code FTM·2011-12-22
K112515 — PENCAN SPINAL NEEDLEB.Braun Medical, Inc.·Product code BSP·2011-12-22
K112776 — TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZERTomotherapy Incorporated·Product code MUJ·2011-12-22
K112783 — MANUJET IIIVBM Medizintechnik GmbH·Product code BTL·2011-12-22
K112907 — CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20GMedos International SARL·Product code NDN·2011-12-22
K113140 — VARI-LASE WIREFIBER LASER FIBERVascular Solutions, Inc.·Product code GEX·2011-12-22
K113244 — SYNAPSE MPR FUSIONFujifilm Medical System U.S.A., Inc.·Product code LLZ·2011-12-22
K113591 — COLS PEEKFournitures Hospitalieres Industrie·Product code HWC·2011-12-22
K110794 — AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITSAmeco Medical Industries·Product code FOZ·2011-12-21
K111055 — GALAXY SYSTEM; JUPITERPersonal Health Institute International·Product code OLV·2011-12-21
K111303 — DERMATOLOGICAL TREATMENT DEVICE FAMILYSharplight Technologies, Ltd.·Product code GEX·2011-12-21
K111446 — SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEMAbbott Medical Optics, Inc.·Product code HQC·2011-12-21
K112274 — U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEMTaidoc Technology Corporation·Product code DXN·2011-12-21
K112302 — PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSESCooperVision, Inc.·Product code LPL·2011-12-21
K112317 — FM-9000 PLUS FETAL AND MATERNAL MONITORAdvanced Instrumentations, Inc.·Product code HGM·2011-12-21
K112437 — ARTHREX FRACTURE SYSTEMArthrex, Inc.·Product code HTN·2011-12-21
K112506 — XPRESS MULTI-SINUS DILATION TOOLEntellus Medical, Inc.·Product code LRC·2011-12-21
K112521 — FUKUDA DENSHI VASERA MODEL VS-1500Fukuda Denshi USA, Inc.·Product code DXN·2011-12-21
K112657 — AUREFLO MONITORING SYSTEMTransonic Systems, Inc.·Product code DPW·2011-12-21
K112920 — RANGE SPINAL SYSTEM (MESA AND DENALI)K2m, Inc.·Product code MNI·2011-12-21
K113044 — SYNTHES MIRSSynthes Spine·Product code NKB·2011-12-21
K113075 — EMBRYO VIEWER SOFTWAREUnisense Fertilitech A/S·Product code MQG·2011-12-21
K113176 — MYSENSE HEARTCardiac Science Corporation·Product code DSH·2011-12-21
K113251 — SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATESSynthes, Inc.·Product code JEY·2011-12-21
K113427 — FRESENIUS 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America·Product code KDI·2011-12-21
K113444 — N-HYBRIDE-COMPOSITE LC FLOWVoco GmbH·Product code EBF·2011-12-21
K113479 — OPTIMEDICA CATALYS PRECISION LASER SYSTEMOptimedica Corporation·Product code OOE·2011-12-21
K113493 — TCX-I REMOTE CARE MANAGEMENT SYSTEMBl Healthcare, Inc.·Product code DRG·2011-12-21
K113563 — N-HYBRIDE-COMPOSITE LCVoco GmbH·Product code EBF·2011-12-21
DEN100013 — VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50Vioguard·Product code OSZ·2011-12-20
K101926 — FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEMTaidoc Technology Corporation·Product code NBW·2011-12-20
K102499 — DUOFERTILITYCambridge Temperature Concepts , Ltd.·Product code LHD·2011-12-20
K102921 — ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIESBema-GmbH & Co. KG·Product code GEI·2011-12-20
K103022 — KIMNeomedic International S.L.·Product code OTN·2011-12-20
K103508 — UNMIAX LAPAROSCOPIC INSTRUMENTUnimax Medical Systems, Inc.·Product code GEI·2011-12-20
K103554 — METRON-CP/MDEponatech, LLC·Product code LLZ·2011-12-20
K112102 — MICHELE SLEEP SCORING SYSTEMSYounes Sleep Technologies·Product code MNR·2011-12-20
K112430 — I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGEAbbott Pont of Care, Inc.·Product code KHP·2011-12-20
K112941 — LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTSSmith & Nephew, Inc.·Product code JWH·2011-12-20
K113004 — PDS(TM) BARBED SUTURESETHICON, Inc.·Product code NEW·2011-12-20
K113028 — MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURSMedisiss·Product code HRX·2011-12-20
K113043 — DIRECT ANTIBIOTIC INFUSION KITSummit Medical Products, Inc.·Product code LJS·2011-12-20
K113136 — 21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)Totoku Electric Co., Ltd.·Product code LLZ·2011-12-20
K113399 — IFS SUBTALAR IMPLANTInternal Fixation Systems, Inc.·Product code HWC·2011-12-20
K113468 — ELM PTA BALLON DILATATION CATHETERCreagh Medical, Ltd.·Product code LIT·2011-12-20
K113523 — LIMACORPORATE SMR REVERSE SHOULDER SYSTEMLima Corporate S.P.A.·Product code PHX·2011-12-20
K113528 — CLYDESDALE(R) SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code MAX·2011-12-20
K113534 — HEALIX KNOTLESS ANCHORDepuy Mitek, A Johnson & Johnson Company·Product code MAI·2011-12-20
K113598 — POWER-LOAD COT FASTENER SYSTEMStryker Medical·Product code FPO·2011-12-20
K102851 — NOFACT VIIIR2 Diagnostics, Inc.·Product code GJT·2011-12-19
K102908 — NOFACT IXR2 Diagnostics, Inc.·Product code GJT·2011-12-19
K110895 — ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESISOrtho Solutions Limited·Product code HWC·2011-12-19
K111013 — ACEMSandhill Scientific, Inc.·Product code FFZ·2011-12-19
K111831 — MX-7000 MICROXELBio-Med USA, Inc.·Product code ONG·2011-12-19
K112056 — ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODELEthicon Endo-Surgery, LLC·Product code GDW·2011-12-19
K112443 — ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)Axis-Shield Diagnostics, Ltd.·Product code CDD·2011-12-19
K112587 — ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,Terumo Cardiovascular Systems Corp.·Product code DWB·2011-12-19
K112704 — LIPIFLOW THERMAL PULSATION SYSTEMTearscience, Inc.·Product code ORZ·2011-12-19
K112862 — MECTA-CMedacta International·Product code ODP·2011-12-19
K112885 — ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLYZimmer, Inc.·Product code HWC·2011-12-19
K112926 — AXSOS LOCKING PLATE SYSTEMStryker Corp.·Product code HRS·2011-12-19
K112990 — ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLEArthrex, Inc.·Product code HTY·2011-12-19
K113434 — LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)Lanx, Inc.·Product code NKB·2011-12-19
K112997 — HD-IVUS ULTRASOUND IMAGING SYSTEMSilicon Vally Medical Instruments, Inc.·Product code IYN·2011-12-17
K113226 — 8MP COLOR LCD MONITOR,RADIFORCE RX840Eizo Nanao Corporation·Product code LLZ·2011-12-17
K113448 — BIOGRAPH MCT FAMILYSiemens Medical Solutions USA, Inc.·Product code KPS·2011-12-17
K100919 — PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202B-K Medical Aps·Product code IYN·2011-12-16
K102712 — MED GRAVITY SET, IMED PUMP SETImed Technology, Inc.·Product code KNT·2011-12-16
K110184 — LIQUIBAND FLOW CONTROLMedlogic Global Limited·Product code MPN·2011-12-16
K110360 — PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDESWrightmedicaltechnologyinc·Product code HSN·2011-12-16
K110603 — HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)I.E.M. GmbH·Product code DXN·2011-12-16
K110793 — AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITSAmeco Medical Industries·Product code MPB·2011-12-16
K110881 — ULTRASONIC SURGICAL UNITDong IL Technology , Ltd.·Product code DZI·2011-12-16
K111514 — SBV2, MULTICHARGER MODEL MC10V2Sleep Performance D.B.A. Fatigue Science·Product code LEL·2011-12-16
K112048 — IMMUNOCARD C. DIFFICILE GDHMeridian Bioscience, Inc.·Product code MCB·2011-12-16
K112055 — AMSCO CHIMERON MEDIUM STEAM STERILIZERSTERIS Corporation·Product code FLE·2011-12-16
K112289 — DISPOSABLE THERMOMETER COVERS AND SHEATHSKang ZE Industrial Co. Limited·Product code FLL·2011-12-16
K112388 — LANX CERVICAL SALanx, Inc.·Product code OVE·2011-12-16
K112424 — VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)Nanosphere, Inc.·Product code NQX·2011-12-16
K112428 — NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFTNovabone Products, LLC·Product code LYC·2011-12-16
K112613 — INTEGRITY(TM)Elekta Limited·Product code IYE·2011-12-16
K112623 — AIRLIGHT DENTAL HANDPIECEBeyes Dental Canada, Inc.·Product code EFB·2011-12-16
K112722 — GE DATEX-OHMEDA AVANCEDatex-Ohmeda, Inc.·Product code BSZ·2011-12-16
K112733 — ER35 ERO-SCAN PRO HEARING TEST SYSTEMEtymotic Research, Inc.·Product code EWO·2011-12-16
K112743 — SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABELClean Medical Manfacturing Co;Ltd·Product code LYZ·2011-12-16
K112752 — TINNITUS THERAPY SYSTEM ANM T30 CRAnm Adaptive Neuromodulation GmbH·Product code KLW·2011-12-16
K112770 — NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETERNinepoint Medical, Inc.·Product code NQQ·2011-12-16
K112819 — RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREWXiamen Double Engline Medical Material Co., Ltd.·Product code HRS·2011-12-16
K112869 — EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400Beyes Dental Canada, Inc.·Product code EFB·2011-12-16
K112913 — SPOTLIGHT ACCESS SYSTEMJohnson & Johnson·Product code GZT·2011-12-16
K112987 — TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEMBiolitec Medical Devices, Inc.·Product code GEX·2011-12-16

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