FDA 510(k) clearances — page 473

176,542 clearances on record, most recent first.

Clearances — page 473

47,201–47,300 of 176,542

K111613 — XELIS FUSIONInfinitt Co., Ltd.·Product code LLZ·2011-09-08
K111802 — SV BRAIN ARRAY, SIEMENS 3TMri Interventions, Inc.·Product code MOS·2011-09-08
K112209 — PREFILLED CATHETER INFLATION SYRINGEAvail Medical Products, Inc.·Product code KNY·2011-09-08
K112310 — WONDFO METHADONE URINE TEST,OPIATE TESTGuangzhou Wondfo Biotech Co., Ltd.·Product code DJG·2011-09-08
K112329 — OMNI PATIENT MONITORInfinium Medical·Product code MWI·2011-09-08
K112386 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMColoplast Corp.·Product code OTP·2011-09-08
K102944 — CORELEADER HEMO-PAD MODEL CPII 02030Coreleader Biotech Co., Ltd.·Product code QSY·2011-09-07
K110637 — ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEMCilag GmbH International·Product code LFR·2011-09-07
K111666 — EVADYNE TEMPORARY CROWN AND BRIDGE RESINNeodental Chemical Products Co., Ltd.·Product code EBG·2011-09-07
K111696 — OPAL BAND CEMENTUltradent Products, Inc.·Product code DYH·2011-09-07
K111729 — PILOT SPINAL SYSTEMLife Spine, Inc.·Product code NKB·2011-09-07
K112272 — EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEMEps Bio Technology Corp.·Product code LFR·2011-09-07
K112399 — UNITE BIOMATRIXSynovis Orthopedic & Woundcare·Product code KGN·2011-09-07
K111329 — NM-7000Nuga Medical Co., Ltd.·Product code JFB·2011-09-06
K111472 — HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICONTgm Medical·Product code LPH·2011-09-06
K111650 — IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...Immunodiagnostic Systems , Ltd.·Product code JJX·2011-09-06
K111734 — MYSAFETY SYRINGEMedicalchain Intl. Corp.·Product code MEG·2011-09-06
K111765 — FULL CORE BIOPSY SYSTEMPromex Technologies, LLC·Product code KNW·2011-09-06
K112245 — XTRASorin Group Italia S.R.L.·Product code CAC·2011-09-06
K112324 — CERALAS 980NM DIODE LASER FAMILYBiolitec Medical Devices, Inc.·Product code GEX·2011-09-06
K101631 — FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation·Product code NBW·2011-09-02
K102933 — GEM-TONE BODY TRAINING SYSTEMGemore Technology Co, Ltd.·Product code NGX·2011-09-02
K110429 — PROSIM 4, PROSIM 6, PROSIM 8Fluke Biomedical·Product code DRT·2011-09-02
K110791 — BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTIONZimmer, Inc.·Product code KWT·2011-09-02
K110860 — COMP A-I-ROmron Healthcare, Inc.·Product code CAF·2011-09-02
K111139 — DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR UAnsell Healthcare Products, Inc.·Product code KGO·2011-09-02
K111682 — DIGITAL RADIOGRAPHYCanon Inc. -Medical Equipment Group·Product code MQB·2011-09-02
K111685 — IP TEMP CEMENTShofu Dental Corporation·Product code EMA·2011-09-02
K111810 — AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITSSTERIS Corporation·Product code MLR·2011-09-02
K112237 — MICROSUTURE ANCHORSArthrex, Inc.·Product code HWC·2011-09-02
K112309 — DIGITAL RADIOGRAPHYCanon Inc. -Medical Equipment Group·Product code MQB·2011-09-02
K103331 — VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSESSTERIS Corporation·Product code JOJ·2011-09-01
K103358 — ROMA (HE4 EIA + ARCHITECT CA 125 II)Fujirebio Diagnostics,Inc.·Product code ONX·2011-09-01
K103808 — SAPPHIRE NCOrbusneich Medical, Inc.·Product code LOX·2011-09-01
K110062 — MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AGMedipurpose Pte. , Ltd.·Product code FRO·2011-09-01
K110565 — ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACEBiomet 3i, Inc.·Product code NHA·2011-09-01
K110729 — ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEMFujifilm Medical Systems U.S.A, Inc.·Product code MUE·2011-09-01
K110944 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVESWangda Plastic Co., Ltd.·Product code LYZ·2011-09-01
K111059 — GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)Gyrus Acmi, Inc.·Product code HIN·2011-09-01
K111143 — POLY-CHEM 90 TOTAL BILIRUBINPolymedco, Inc.·Product code CIG·2011-09-01
K112199 — XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)Luminex Molecular Diagnostics, Inc.·Product code OCC·2011-09-01
K112213 — VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEMGE Healthcare·Product code IYN·2011-09-01
K112311 — ALP 501 RB PUMP SYSTEMCurrie Medical Specialties, Inc.·Product code JOW·2011-09-01
K112349 — VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCARCovidien, Formerly US Surgical A Divison of Tyco H·Product code GCJ·2011-09-01
K112421 — EMG SUCTION UNITEmg Technology Co., Ltd.·Product code JCX·2011-09-01
K101204 — MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTIONApex BioTechnology Corp.·Product code CGA·2011-08-31
K101635 — TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation·Product code NBW·2011-08-31
K103747 — ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYSElitechgroup Seppim S.A.S.·Product code LBS·2011-08-31
K111032 — CMC CABLE FIXInstratek, Inc.·Product code HTN·2011-08-31
K111314 — MORPHEUS OXWidemed, Ltd.·Product code MNR·2011-08-31
K111742 — MDRIVEEmbla Systems·Product code MNR·2011-08-31
K111913 — CAPSURE(R) PS SYSTEMSpine Wave, Inc.·Product code MNI·2011-08-31
K112239 — STEERABLE GUIDE CATHETERAbbott Vascular·Product code DRA·2011-08-31
K112376 — S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEMCirca Scientific, LLC·Product code FLL·2011-08-31
K101543 — TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200Tyson Bioresearch, Inc.·Product code NBW·2011-08-30
K110129 — RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTIONRightmedical Products, LLC·Product code HJO·2011-08-30
K110289 — FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODEXian Friendship Medical Electronics Co., Ltd.·Product code GXY·2011-08-30
K111236 — INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1B.Braun Melsungen AG·Product code FOZ·2011-08-30
K111308 — ZYTO HAND CRADLEZyto Technologies, Inc.·Product code GZO·2011-08-30
K111433 — DEPUY STTUNE (TM) PS KNEE SYSTEMDePuy Orthopaedics, Inc.·Product code OIY·2011-08-30
K111548 — WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SEFujifilm Medical System U.S.A., Inc.·Product code MQB·2011-08-30
K111817 — PALINDROME RT CHRONIC CATHETERCovidien·Product code MSD·2011-08-30
K111942 — TSRH SPINAL SYSTEMSMedtronic Sofamor Danek USA, Inc.·Product code NKB·2011-08-30
K112029 — ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05Elitechgroup·Product code JIX·2011-08-30
K112163 — MONICA IF24Monica Healthcare·Product code OSP·2011-08-30
K083577 — HARMONIE SYSTEMStellate Systems·Product code GWQ·2011-08-29
K091960 — VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020Abbott Molecular, Inc.·Product code OWK·2011-08-29
K103308 — AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVEKARL STORZ Endoscopy-America, Inc.·Product code LLZ·2011-08-29
K103799 — INQU PASTE MIX PLUSIsto Technologies, Inc.·Product code MQV·2011-08-29
K110648 — NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEMNova Biomedical Corporation·Product code CHL·2011-08-29
K110756 — BLUEPHASE STYLEIvoclar Vivadent, Inc.·Product code EBZ·2011-08-29
K111172 — 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIESDaavlin Distributing Co.·Product code FTC·2011-08-29
K111374 — SONO-SERIES CORNERSTONE TECHNIQUEPAJUNK GmbH Medizintechnologie·Product code BSP·2011-08-29
K111386 — MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)Smiths Medical MD, Inc.·Product code FRN·2011-08-29
K111572 — NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODELSerf·Product code LZO·2011-08-29
K111608 — SLIC SCREW REPAIR SYSTEMAcumed, LLC·Product code HWC·2011-08-29
K112339 — ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEMSamsung Medison Co., Ltd.·Product code IYN·2011-08-29
K112341 — SNAP WOUND CARE SYSTEMSpiracur, Inc.·Product code OKO·2011-08-29
K112409 — MATRISTEM WOUND MATRIXAcell, Inc.·Product code KGN·2011-08-29
K102678 — ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMSAndon Medical Co., Ltd.·Product code NBW·2011-08-26
K103087 — COVAMAX RESORBABLE COLLAGEN MEMBRANEBiom'Up Sas·Product code NPL·2011-08-26
K103181 — ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMGenoray Co., Ltd.·Product code LLZ·2011-08-26
K103532 — AUTOREADER 2Trek Diagnostic Systems·Product code LRG·2011-08-26
K110269 — WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORALWell Lead Medical Co., Ltd.·Product code BTR·2011-08-26
K110451 — ENDOWRIST ONE SUCTION/IRRIGATORIntuitive Surgical, Inc.·Product code NAY·2011-08-26
K111301 — INSTINCT JAVA SYSTEMZimmer Spine·Product code NKB·2011-08-26
K111535 — EMM SURGICAL GOWN - SPUNLACE WITH PE LAYERExact Medical Manufacturing, Inc.·Product code FYA·2011-08-26
K111573 — MONOBLOC BM SERIESHass Corp.·Product code EIH·2011-08-26
K112137 — COMFORTGLIDE INTERMITENT CATHETERC.R. Bard, Inc.·Product code EZD·2011-08-26
K112182 — ANGIOSCULPT PTA SCORING BALLOON CATHETERAngioscore, Inc.·Product code PNO·2011-08-26
K112235 — AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGAirstrip Technologies, LP·Product code MWI·2011-08-26
K101234 — VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODYVentana Medical Systems, Inc.·Product code OWF·2011-08-25
K102926 — GEMORE MUSCLE CONDITIONERGemore Technology Co, Ltd.·Product code NGX·2011-08-25
K110733 — DAYTONA ANTERIOR CERVICAL CAGESpinenet, LLC·Product code ODP·2011-08-25
K110934 — ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAYSiemens Healthcare Diagnostics·Product code LCP·2011-08-25
K110977 — VESOFLOWCaremed Supply, Inc.·Product code JOW·2011-08-25
K111101 — NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SETNorfolk Medical·Product code LJT·2011-08-25
K111482 — SONICATOR PLUS 920Mettler Electronics Corp.·Product code IMG·2011-08-25
K111584 — XYLOS MACRO-POROUS SURGICAL MESHXylos Corporation·Product code FTM·2011-08-25
K111592 — YOULASER CO2 LASER SYSTEMQuanta System Spa·Product code GEX·2011-08-25

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