FDA 510(k) clearances — page 444

176,542 clearances on record, most recent first.

Clearances — page 444

44,301–44,400 of 176,542

K120668 — SENTINELC-Rad Positioning AB·Product code IYE·2012-07-30
K121231 — IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TESTInd Ndiagnostic, Inc.·Product code NGT·2012-07-30
K121292 — DYNAPBV BODY SOFTWARESiemens Medical Solutions USA, Inc.·Product code LLZ·2012-07-30
K121299 — STERISPINEPS PEDICLE SCREW, STERISPINEPS RODSafe Orthopaedics·Product code NKB·2012-07-30
K121301 — XPRESSWAY RX CATHETER (6F LD-VERISON)Kaneka Pharma America, LLC·Product code QEZ·2012-07-30
K121308 — HIP SYSTEMSHowmedica Osteonics Corp.·Product code LPH·2012-07-30
K121544 — DYNASTY BIOFOAM SHELLWrightmedicaltechnologyinc·Product code KWA·2012-07-30
K121734 — PLATO MICROCATH 27 MICROCATHETERScientia Vascular, LLC·Product code DQO·2012-07-30
K103555 — MULTIPLATE 5.0 AGGREGOMETERVerum Diagnostica GmbH·Product code JOZ·2012-07-27
K110425 — HC-BIOS DENTAL IMPLANTHung Chun Bio-S Co., Ltd.·Product code DZE·2012-07-27
K113073 — IO-TOME DEVICEBaxano, Inc.·Product code HAE·2012-07-27
K113307 — GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEMHmd Biomedical, Inc.·Product code LFR·2012-07-27
K113489 — ORIONAsclepion Laser Technologies GmbH·Product code GEX·2012-07-27
K113544 — ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGERProspera Corporation·Product code GZJ·2012-07-27
K120202 — EON CHOLESTEROL REAGENTVital Diagnostics Pty., Ltd.·Product code CHH·2012-07-27
K120230 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILEShandong Taixiang Medical Products Co., Ltd.·Product code LYZ·2012-07-27
K120463 — MOJO, VERASEALSleepnet Corporation·Product code BZD·2012-07-27
K120797 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Shandong Shouguang Kingliyuan Medical Apparatus &·Product code LYZ·2012-07-27
K120926 — ENDOBEAM HOLMIUM LASER FIBERSC.R. Bard, Inc.·Product code GEX·2012-07-27
K121338 — ZEOBIIvivi Health Science, LLC·Product code ILX·2012-07-27
K121359 — IPS 99 ONE AND IPS 99 CERAMIvoclar Vivadent, AG·Product code EIH·2012-07-27
K121569 — MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEMAccel Spine·Product code ODP·2012-07-27
K121604 — ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHTObp Corporation·Product code FER·2012-07-27
K121617 — SENSICARDIACDiacoustic Medical (Pty)·Product code DQD·2012-07-27
K121748 — THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELLAccess Scientific, Inc.·Product code DYB·2012-07-27
K121879 — VEGA KNEE SYSTEMAesculap Implant Systems·Product code JWH·2012-07-27
K121897 — PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVESCardinal Health, Inc.·Product code KGO·2012-07-27
K110898 — S.C.O.R.E.S. UNITAmmed Surgical Equipment, LLC·Product code KCT·2012-07-26
K111260 — A/C ENZYMATIC VITAMIN B6 ASSAYAnticancer, Inc.·Product code CDD·2012-07-26
K112391 — FUJINON COLONOSCOPESFujinon, Inc.·Product code FDF·2012-07-26
K113285 — LDR SPINE USA AVENUE L INTERBODY FUSIONLdr Spine USA, Inc.·Product code OVD·2012-07-26
K113397 — ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMZeus Scientific, Inc.·Product code LSR·2012-07-26
K113656 — CAREGUIDE OXIMETERReflectance Medical, Inc.·Product code MUD·2012-07-26
K113869 — ORIGEN REINFORCED DUAL LUMEN CATHETEROrigen Biomedical, Inc.·Product code DWF·2012-07-26
K120016 — PIONEER STERNAL ASSIST IMPLANT SYSTEMPioneer Surgical Technology, Inc.·Product code HRS·2012-07-26
K120509 — STRYKER ALL SUTURE ANCHORSStryker·Product code MBI·2012-07-26
K120753 — CLARISCTIcrco, Inc.·Product code OAS·2012-07-26
K120896 — WI-FI BODY SCALEAndon Health Co, Ltd.·Product code MNW·2012-07-26
K120993 — GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADERVarian Medical Systems, Inc.·Product code JAQ·2012-07-26
K121013 — CONNEX VITAL SIGNS MONITOR 6000 SERIESWelch Allyn, Inc.·Product code MWI·2012-07-26
K121075 — NERVEVISION SOFTWARE SYSTEMS3D Imaging Partners, Inc.·Product code LLZ·2012-07-26
K121183 — COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMSBiomet Corporation·Product code PHX·2012-07-26
K121190 — CONTOUR NEXT BLOOD GLUCOSE METERBayer Healthcare, LLC·Product code LFR·2012-07-26
K121293 — CS-SERIES-FP WITH 3030+OPTIONOmega Medical Imaging, LLC·Product code JAA·2012-07-26
K121303 — MOBILE C-ARMCanon Inc. -Medical Equipment Group·Product code OXO·2012-07-26
K121512 — SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMBio-Logic Systems Corp.·Product code EWO·2012-07-26
K121553 — AQUILION RXLToshibamedical Systems Corporation·Product code JAK·2012-07-26
K121888 — E-CUBE 15Alpinion Medical Systems Co., Ltd.·Product code IYO·2012-07-26
K121905 — ALERE PBP2A TESTAlere Scarborough, Inc.·Product code MYI·2012-07-26
K121909 — INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIORSorin Group Italia S.R.L.·Product code DTZ·2012-07-26
K121922 — BEACON STABILIZATION SYSTEMGlobus Medical, Inc.·Product code NKB·2012-07-26
K121937 — E-CUBE INNOAlpinion Medical Systems Co., Ltd.·Product code IYN·2012-07-26
K121950 — MICROTARGETING XL STAR DRIVE SYSTEMFHC, Inc.·Product code HAW·2012-07-26
K121982 — SOVEREIGN SPINAL SYSTEMMedtronic Sofamor Danek·Product code OVD·2012-07-26
K122095 — ICP TRIAGEMANAGEREmergo Europe Consulting BV·Product code DRG·2012-07-26
K111465 — COMPOTHIXOKerrhawe SA·Product code DZN·2012-07-25
K120176 — SENZZZZZ AWAYCentrix, Inc.·Product code LBH·2012-07-25
K120262 — HLS UNI EVOLUTION & U-KNEETECTornier, Inc.·Product code HSX·2012-07-25
K120377 — ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-AJ. Morita USA, Inc.·Product code GEX·2012-07-25
K120625 — ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSVRoche Diagnostics·Product code MXJ·2012-07-25
K120914 — FLEXITIME FAST & SCAN LIGHT FLOWHeraeus Kulzer, LLC·Product code ELW·2012-07-25
K120958 — POSISEP AND POSISEP X HEMOSTAT DRESSINGSHemostasis, LLC·Product code QSY·2012-07-25
K120988 — DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHTMedtronic, Inc.·Product code DWF·2012-07-25
K121134 — TL TRISEB CREAMTrigen Laboratories, Inc.·Product code FRO·2012-07-25
K121195 — NVISION VLE IMAGING SYSTEM NVISION VLE CATHETERNinepoint Medical, Inc.·Product code NQQ·2012-07-25
K121252 — HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEMStryker Corp.·Product code KTT·2012-07-25
K121275 — AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBERConvatec, Inc.·Product code FRO·2012-07-25
K121510 — IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTERCovidien, Formerly US Surgical A Divison of Tyco H·Product code GDW·2012-07-25
K121557 — WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TESTGuangzhou Wondfo Biotech Co., Ltd.·Product code LDJ·2012-07-25
K121583 — CLEARFIL MAJESTY FLOWKuraray Noritake Dental, Inc.·Product code EBF·2012-07-25
K121852 — SYNTHES ZERO-P VARIABLE ANGLE (VA)Synthes Spine Co.Lp·Product code OVE·2012-07-25
K121908 — SAFETY INFUSION SETGreiner Bio-One North America, Inc.·Product code FMI·2012-07-25
K113546 — ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5Roche Diagnostics·Product code MRG·2012-07-24
K120566 — O2PAK OXYGEN GENERATORPacific Precision Products·Product code CAW·2012-07-24
K121282 — MICROLUX/DL MICROLUX/BLU BIO/SCREENAddent, Inc.·Product code NXV·2012-07-24
K121376 — COMPRESSION CARE FLIGHTMedical Minds, LLC·Product code JOW·2012-07-24
K121759 — CONE-TROL LIQUID CHEMISTRY CONTROLSCone Bioproducts·Product code JJY·2012-07-24
K121912 — E1 EAR SENSORSMasimo Corporation·Product code DQA·2012-07-24
K121229 — INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMYSorin Group Italia S.R.L.·Product code DTZ·2012-07-23
K121788 — NIO 5MPBarco N.V.·Product code LLZ·2012-07-23
K121907 — DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATORSiemens Healthcare Diagnostics·Product code CJO·2012-07-23
K112389 — SURGICASE CONNECT, SURGICASE GUIDEMaterialise NV·Product code PBF·2012-07-20
K113162 — SLIDEWIRETM(TRADEMARK PENDING)Acme-Monaco Corp.·Product code DQX·2012-07-20
K113229 — VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATINGC.R. Bard, Inc.·Product code FTL·2012-07-20
K113498 — DISPOSABLE TORQUE DEVICECoeur, Inc.·Product code DQX·2012-07-20
K120569 — GEMORE TENS SYSTEMGemore Technology Co, Ltd.·Product code GZJ·2012-07-20
K120839 — NOVACATH SECURE IV CATHETER SYSTEM-18GTangent Medical Technologies, Inc.·Product code FOZ·2012-07-20
K120849 — HYBRID ARCTICGEL PADMedivance, Inc.·Product code DWJ·2012-07-20
K121159 — INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTERIntegra Lifescience Corportation·Product code GWM·2012-07-20
K121416 — GMK SPHEREMedacta International·Product code JWH·2012-07-20
K121441 — CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)Bovie Medical Corporation·Product code HQP·2012-07-20
K121517 — VERSAVUE ENTERPRISE SUITEIcad, Inc.·Product code LLZ·2012-07-20
K121612 — ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATIONAmerican Medical Systems·Product code OTP·2012-07-20
K121658 — ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)Orthofix, Inc.·Product code KWQ·2012-07-20
K121808 — CASIAN, 3.5/4.5 CONNECTORSK2m, Inc.·Product code KWP·2012-07-20
K121835 — DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VEEncore Medical L.P.·Product code JWH·2012-07-20
K121948 — CR 10-X DIGITIZERAgfa Healthcare N.V.·Product code MQB·2012-07-20
K122010 — Z6 DIAGNOSTIC ULTRASOUND SYSTEMShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYN·2012-07-20
K111401 — BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBEHangzhou Bever Medical Devices Co., Ltd.·Product code BTR·2012-07-19
K111406 — BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)Hangzhou Bever Medical Devices Co., Ltd.·Product code BTR·2012-07-19

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