FDA 510(k) clearances — page 462

176,542 clearances on record, most recent first.

Clearances — page 462

46,101–46,200 of 176,542

K111623 — I-ENDO DUALSatelec - Acteon Group·Product code EBW·2012-01-10
K111761 — NEO TITANIUM MESH, CTI-MEMNeobiotech Co., Ltd.·Product code JEY·2012-01-10
K112332 — FINE JECT INSULIN PEN NEEDLETwobiens Co., Ltd.·Product code FMI·2012-01-10
K113138 — ALEUTIAN SYSTEMK2m, Inc.·Product code MAX·2012-01-10
K113351 — CORTRAK ENTERAL ACCESS DEVICECorpak Medsystems·Product code KNT·2012-01-10
K113625 — DSS STABILIZATION SYSTEMParadigm Spine, LLC·Product code NKB·2012-01-10
K113758 — VOLUSON E6/E8/E8EXPERT/E10GE Healthcare·Product code IYE·2012-01-10
K112258 — NEUROTECH PLUSBio-Medical Research, Ltd.·Product code GZJ·2012-01-09
K112514 — APNEA RISK EVALUATION SYSTEM (ARES)Advanced Brain Monitoring, Inc.·Product code MNR·2012-01-09
K112960 — LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURECayenne Medical, Inc.·Product code MBI·2012-01-09
K113071 — SYNTHECEL DURA REPLACEMENT DEVICESSynthes·Product code GXQ·2012-01-09
K110559 — AVITA INFRARED THEROMETER WITH BLUETOOTHAvita Corporation·Product code FLL·2012-01-06
K111165 — KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULEKARL STORZ Endoscopy-America, Inc.·Product code ODA·2012-01-06
K111730 — SONOTT FLOWLAB(R)Em-Tec GmbH·Product code DPW·2012-01-06
K111861 — SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINESiemens Medical Systems USA·Product code LLZ·2012-01-06
K112008 — TOUCHPACS SUITETouch Medical Solutions, Inc.·Product code LLZ·2012-01-06
K112046 — MTA ANGELUSAngelus Industria DE Productos Odontologicos·Product code KIF·2012-01-06
K112060 — RADIANCEGmv Aerospace and Defence S.A.·Product code MUJ·2012-01-06
K112169 — APTUS WRIST ARTHRODESIS PLATESMedartis AG·Product code HRS·2012-01-06
K112301 — ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNERMaterialise NV·Product code HSX·2012-01-06
K112523 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KITSiemens Healthcare Diagnostics, Inc.·Product code DHB·2012-01-06
K113127 — MIRAGE QUATTROResmed, Ltd.·Product code BZD·2012-01-06
K113137 — GLUCOSE TEST SYSTEMRoche Diagnostics·Product code NBW·2012-01-06
K113159 — U-RIGHT TD-1240 THERMOMETERTaidoc Technology Corporation·Product code FLL·2012-01-06
K113477 — IVAS 20MM (10 GAUGE) BALLOON CATHETERStryker Instruments, Instruments Div.·Product code NDN·2012-01-06
K111103 — DIGITAL X-RAY IMAGING SYSTEMRf Co., Ltd.·Product code MUH·2012-01-05
K111717 — ELECTRO-GELElectro-Cap Intl., Inc.·Product code GYB·2012-01-05
K112035 — VALET MICRO CATHETERVolcano Corporation·Product code DQY·2012-01-05
K112454 — HALO60 ABLATION CATHETERBarrx Medical, Inc.·Product code GEI·2012-01-05
K112458 — PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEMMedica-Rents Co., Ltd.·Product code OMP·2012-01-05
K112557 — STRYKER UNIVERSAL NEURO 3 SYSTEMStryker·Product code GWO·2012-01-05
K112955 — NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEMNova Biomedical Corporation·Product code KHP·2012-01-05
K113012 — PROMOS MODULAR SHOULDER SYSTEMSmith & Nephew, Inc.·Product code KWS·2012-01-05
K113038 — SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTSSmith & Nephew, Inc.·Product code HSX·2012-01-05
K113242 — APEX ARC HIP STEMOmni Life Science, Inc.·Product code LPH·2012-01-05
K113638 — NMI 2.8 MICROCATHETERNavilyst Medical, Inc.·Product code DQO·2012-01-05
K113708 — ORTHOSCAN MOBILE DI MINI C-ARMOrthoscan, Inc.·Product code OXO·2012-01-05
K112240 — DYNA LOCKING CANNULATED SCREWU&I Corp.·Product code HWC·2012-01-04
K112643 — FOCUS MIS SYSTEML&K BIOMED Co., Ltd.·Product code NKB·2012-01-04
K112890 — NORMATEC MVPNormaTec Industries, LP·Product code IRP·2012-01-04
K113106 — DNE EXTERNAL FIXATION SYSTEMDne, LLC·Product code KTT·2012-01-04
K113187 — AVIVO MOBILE PATIENT MANAGEMENTCorventis, Inc.·Product code MHX·2012-01-04
K113211 — HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROLInstrumentation Laboratory CO·Product code GGN·2012-01-04
K113237 — CERTUS 140 2.45GHZ ABLATION SYSTEMNeuwave Medical, Inc.·Product code NEY·2012-01-04
K113589 — BIGBOSS CATHETERBridgepoint Medical·Product code DQY·2012-01-04
K113609 — NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5Exactech, Inc.·Product code LPH·2012-01-04
K111068 — STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5Skeletal Dynamics, LLC·Product code KYI·2011-12-30
K111149 — HANAROSTENT BILIARY (NNN)M.I.Tech Co., Ltd.·Product code FGE·2011-12-30
K111403 — MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIESMasimo Corporation·Product code DQA·2011-12-30
K111985 — MYOGUIDE SYSTEM MODEL 8008Intronix Technologies Corp.·Product code BXN·2011-12-30
K112522 — FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEMFlexible Stenting Solutions, Inc.·Product code FGE·2011-12-30
K112944 — FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIESFresenius Medical Care South Asia Pacific Pty , Ltd.·Product code INO·2011-12-30
K113337 — VISIA DYNAMIC REVIEWMeVis Medical Solutions AG·Product code LNH·2011-12-30
K113373 — DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CALSiemens Healthcare Diagnostics, Inc.·Product code JIT·2011-12-30
K102999 — TRIMOTION INJECTORKaneka Corp.·Product code OTZ·2011-12-29
K112543 — WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEMBoston Scientific Corporation·Product code FGE·2011-12-29
K112778 — SMART SEGMENTATION-KNOWLEDGE BASED CONTOURINGVarian Medical Systems·Product code IYE·2011-12-29
K112914 — VPAP TXResmed, Ltd.·Product code MNS·2011-12-29
K113269 — ELITTECH CLINICAL SYSTEMS ALP IFCC SLElitechgroup·Product code CJE·2011-12-29
K113342 — SOMATOM DEFINITION FLASHSiemens Medical Systems, Inc.·Product code JAK·2011-12-29
K113381 — MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEMSamsung Medison Co., Ltd.·Product code IYN·2011-12-29
K113559 — LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTSLdr Spine USA, Inc.·Product code ODP·2011-12-29
K113630 — DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGARayence Co., Ltd.·Product code MQB·2011-12-29
K113680 — SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KITSoma Access Systems, LLC·Product code IYO·2011-12-29
K113690 — GE LOGIQ I, LOGIQ E AND VIVID EGE Healthcare·Product code IYN·2011-12-29
K103573 — ARTS2 SPINAL FIXATION SYSTEMAdvanced Medical Technologies·Product code MNH·2011-12-28
K110639 — ENDOWRIST ONE VESSEL SEALERIntuitive Surgical, Inc.·Product code NAY·2011-12-28
K111618 — AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTIONNatus Medical Incorporated·Product code EWO·2011-12-28
K111671 — SEASPINE MONOPOLAR PROBE SYSYEMSeaspine, Inc.·Product code ETN·2011-12-28
K111776 — DELTAVIEW MODEL 2.1Riverain Medical Group,Llc·Product code LLZ·2011-12-28
K112080 — PRESERVE HIP STEMWrightmedicaltechnologyinc·Product code KWA·2011-12-28
K112572 — GEISTLICH COMBI-KIT COLLEGENGeistlich Pharma AG·Product code NPM·2011-12-28
K113040 — CERAMIR CROWN & BRIDGEDoxa Dental AB·Product code EMA·2011-12-28
K113283 — NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTSStraumann USA·Product code NHA·2011-12-28
K113317 — LIFECHOICE OXYGEN CONCENTRATORInova Labs, Inc.·Product code CAW·2011-12-28
K112387 — PROCEDURE REHEARSAL STUDIO(TM)Simbionix , Ltd.·Product code LLZ·2011-12-27
K112546 — O_TWO CPAP SYSTEMO-Two Medical Technologies, Inc.·Product code BYE·2011-12-27
K112575 — GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIOGeistlich Pharma AG·Product code NPM·2011-12-27
K112822 — SLEEPSTRIP IIS.L.P. , Ltd.·Product code MNR·2011-12-27
K112923 — SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEMSuspension Orthopaedic Solutions, LLC·Product code HRS·2011-12-27
K112933 — ACCESS THYROGLOBULIN ANITBODYBeckman Coulter, Inc.·Product code JNL·2011-12-27
K110313 — TINA-QUANT HBA1C GEN.2Roche Diagnostics·Product code LCP·2011-12-23
K110717 — KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEMKonica Minolta Medical & Graphic, Inc.·Product code MUE·2011-12-23
K110726 — ROCHE ACETAMINOPHEN ASSAYRoche Diagnostics·Product code LDP·2011-12-23
K111673 — 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COILInvivo Corporation·Product code MOS·2011-12-23
K111680 — DR. GREENSBURG'S HYBRIDAlways More Marketing, Inc.·Product code LRK·2011-12-23
K112352 — GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULTBionostics, Inc.·Product code JJX·2011-12-23
K112412 — AU5800(R) CHEMISTRY ANALYZERBeckman Coulter, Inc.·Product code CEM·2011-12-23
K112499 — BIOMERIX COMPOSITE SURGICAL MESHBiomerix Corporation·Product code FTL·2011-12-23
K112567 — BIOMERIX ASSUREBiomerix Corporation·Product code FTL·2011-12-23
K112664 — ZAVATION IBF SYSTEMSZavation, LLC·Product code ODP·2011-12-23
K112789 — EASY TOUCHMhc Medical Products, LLC·Product code FMI·2011-12-23
K112799 — MED-RX EXTENSION SET WITH T-CONNECTORBenlan, Inc.·Product code FPA·2011-12-23
K112901 — EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEMEps Bio Technology Corp.·Product code LFR·2011-12-23
K113109 — STRYKER RESORBABLE FIXATION SYSTEMStryker·Product code HRS·2011-12-23
K113443 — 21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)Totoku Electric Co., Ltd.·Product code LLZ·2011-12-23
K110198 — BLUE SKY BIO TCPBlue Sky Bio, LLC·Product code LYC·2011-12-22
K110381 — CELL-DYN EMERALD 22 SYSTEMAbbott Laboratories·Product code GKZ·2011-12-22
K110798 — SENOGRAPHE DS, SENOGRAPHE ESSENTIALGeneral Electric Company·Product code MUE·2011-12-22
K111159 — HEARTCHECK PEN HANDHELD ECG WITH GEMS HOMECardiocomm Solutions, Inc.·Product code DPS·2011-12-22

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