FDA 510(k) clearances — page 493

176,542 clearances on record, most recent first.

Clearances — page 493

49,201–49,300 of 176,542

K103036 — ALLOFUSE PLUSAllosource, Inc.·Product code MQV·2011-01-10
K103046 — HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPEHosman International Co., Ltd.·Product code DXN·2011-01-10
K103064 — AVAMAX VERTEBRAL BALLOONCare Fusion·Product code NDN·2011-01-10
K103110 — MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETERAbbott Vascular-Cardiac Therapies·Product code LOX·2011-01-10
K103209 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)Nanosphere, Inc.·Product code OCC·2011-01-10
K103252 — CAMLOG VARIO SR ABUTMENTSAltatec GmbH·Product code NHA·2011-01-10
K093280 — OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561Opti Medical Systems, Inc.·Product code CHL·2011-01-07
K101371 — ON CALL PLUS DIABETES MONITORING SOFTWAREACON Laboratories, Inc.·Product code NBW·2011-01-07
K101588 — ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICALApollo Spine, Inc.·Product code OVE·2011-01-07
K101750 — RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104Reprocessing Products Corp·Product code MNV·2011-01-07
K101823 — ARTHREX SWIVELOCK ANCHORSArthrex, Inc.·Product code MAI·2011-01-07
K101953 — SMDIA-1000Southmedic, Inc.·Product code CAF·2011-01-07
K102184 — MEDPOR CONTAIN CAN IMPLANTPorex Surgical, Inc.·Product code NPK·2011-01-07
K102298 — TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTENDDepuy Mitek, A Johnson & Johnson Company·Product code HWC·2011-01-07
K102304 — BREEZE C MODEL C (3W), BREEZE C (4W)Afikim Electric Vehicles·Product code INI·2011-01-07
K102322 — STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)Omni Surgical, L.P.·Product code MAX·2011-01-07
K102380 — EVOLUTION MP TOTAL KNEE SYSTEMWrightmedicaltechnologyinc·Product code JWH·2011-01-07
K102823 — DISPOSABLE BLOOD PRESSURE CUFFWuxi Medical Instrument Factory·Product code DXQ·2011-01-07
K103043 — COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATHAdapta Medical, Inc.·Product code EZD·2011-01-07
K103117 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.·Product code JWH·2011-01-07
K103152 — 6250 ULTRASOUND SYTEMSEsaote, S.p.A.·Product code IYN·2011-01-07
K103224 — HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBINGHospira, Inc.·Product code FPA·2011-01-07
K103349 — BACKSTOP CATHETERPluromed, Inc.·Product code KOD·2011-01-07
K103402 — ELECSYS DHEA-S CALCHECK 5Roche Diagnostics·Product code JJX·2011-01-07
K103512 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEMHologic, Inc.·Product code IZH·2011-01-07
K103646 — INTELLIVUE MX40 PATIENT MONITORPhillips Medical Systems·Product code MHX·2011-01-07
K100358 — CENTRAL MONITORING SYSTEMEdan Instruments, Inc.·Product code HGM·2011-01-06
K100577 — ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPEAcclarent, Inc.·Product code EOB·2011-01-06
K101024 — KENZ CARDY302 MAXSuzuken Co., Ltd.·Product code MWJ·2011-01-06
K101616 — THE GRAPPLR AND GRAPPLR EXTENDERTag Medical Corp.·Product code MBI·2011-01-06
K102520 — BD NEXIVA CLOSED IV CATHETER SYSTEMBecton Dickinson Infusion Therapy Systems, Inc.·Product code FOZ·2011-01-06
K102649 — NEOPOP INFANT RESUSCITATOR WITH FLOW METERNeoforce Group, Inc.·Product code BTM·2011-01-06
K102683 — THE ADDITIONOb The-Addition, LLC·Product code MUI·2011-01-06
K103160 — NUPRO MODEL 13016901CAO Group, Inc.·Product code LBH·2011-01-06
K103168 — B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)Sorin Group Deutschland GmbH·Product code DRY·2011-01-06
K103610 — CLEARVIEW EXACT II INFLUENZA A & B TESTAlere Scarborough, Inc D/B/A Binax, Inc.·Product code PSZ·2011-01-06
K100613 — BIOMED WOUND CLEANSERBiomed Laboratories, Inc.·Product code FRO·2011-01-05
K101472 — MULTIFIT TOTAL HIP SYSTEMOtis Biotech Co., Ltd.·Product code LZO·2011-01-05
K101693 — GAUNYING INFRARED LAMP MODEL IL50Foshan Gaunying Electronics Co., Ltd.·Product code ILY·2011-01-05
K102293 — CALIBER SPACERGlobus Medical, Inc.·Product code MAX·2011-01-05
K102379 — LTF-Y0009; MAJ-YOO41; XOEV-3D1Olympus Medical Systems Corporation·Product code GCJ·2011-01-05
K102513 — S9 VPAP ST WITH H5IResmed, Ltd.·Product code BZD·2011-01-05
K102544 — SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAYSmith & Nephew Inc., Endoscopy Div.·Product code KCT·2011-01-05
K102698 — PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFEEllman Int'L, Inc.·Product code GEI·2011-01-05
K102703 — BUILD-IT TOTAL COREPentron Clinical·Product code EBF·2011-01-05
K102806 — NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABSAllergan Medical·Product code LCJ·2011-01-05
K102982 — ENDOBUTTON DIRECTSmith & Nephew Inc., Endoscopy Division·Product code MAI·2011-01-05
K103047 — CERETENE SOLUBLE IMPLANT MATERIALCeremed , Inc.·Product code KHJ·2011-01-05
K103060 — ARTHREX TIBIAL GRAFTBOLTArthrex, Inc.·Product code MBI·2011-01-05
K103228 — PARAMOUNT R IBF DEVICETheken Spine, LLC·Product code MAX·2011-01-05
K103287 — SYNTHES 6.0 COCR AND CPT TI-3 RODSSynthes Spine·Product code NKB·2011-01-05
K103475 — SPINEANALYER MODEL SAPOCOptasia Medical·Product code LLZ·2011-01-05
K103534 — GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRETrireme Medical, Inc.·Product code DQY·2011-01-05
K103618 — TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEMEv3, Inc.·Product code MCW·2011-01-05
K103722 — THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEMMedison Co., Ltd.·Product code ITX·2011-01-05
K093595 — CERAROOT IMPLANT SYSTEMOral Iceberg S.L.·Product code DZE·2011-01-04
K101350 — RADSCAN EQUIPMENT SLICKERRadscan Medical Equipment, Inc.·Product code KKX·2011-01-04
K102226 — DUAL INCU IAtom Medical Corporation·Product code FMZ·2011-01-04
K102974 — INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00Philips Medical Systems·Product code MSX·2011-01-04
K102998 — CONGRUENT BONE PLATE SYSTEMAcumed, LLC·Product code HRS·2011-01-04
K103550 — YOBOSHI DENTAL UNITFosham Yoboshi Medical Equipment Co., Ltd.·Product code EIA·2011-01-04
K101853 — PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115Diadexus, Inc.·Product code NOE·2011-01-03
K102284 — KRYSTALRAD 560 (FLAATZ 560)Medicatech USA·Product code KPR·2011-01-03
K102285 — KRYSTALRAD (ATAL8)Medicatech USA·Product code KPR·2011-01-03
K103073 — SUPER CHAIR FOR KIDS BY ORIONFuture Mobility Healthcare, Inc.·Product code IOR·2011-01-03
K103149 — 1.5T 16-CHANNEL HAND-WRIST COILInvivo Corporation·Product code MOS·2011-01-03
K103212 — ROUGHRIDERWhirlwind Wheelchair International·Product code IOR·2011-01-03
K103319 — I-SEEDTheragenics Corp.·Product code KXK·2011-01-03
K103415 — TANDA MAXPharos Life Corporation·Product code ONE·2011-01-03
K103433 — F20Teknimed, S.A.·Product code NDN·2011-01-03
K103597 — DX-D 100Agfa Healthcare N.V.·Product code IZL·2011-01-03
K090105 — LUPOTEK KCTR2 Diagnostics, Inc.·Product code GGW·2010-12-30
K101450 — CANTATA MICROCATHETERCook, Inc.·Product code KRA·2010-12-30
K102616 — NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICESmart Medical Systems , Ltd.·Product code FDF·2010-12-30
K102663 — AED RESECTOSCOPENational Advanced Endoscopy Devices, Inc.·Product code FJL·2010-12-30
K102931 — G-CINCH SUTURE GRASPERUsgi Medical·Product code OCW·2010-12-30
K103122 — C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KGAat Alber Antriebstechnik GmbH·Product code ILK·2010-12-30
K103153 — VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETERAbbott Vascular-Cardiac Therapies·Product code LOX·2010-12-30
K103239 — IRRIGATION SYSTEMUnited States Endoscopy Group, Inc.·Product code OCX·2010-12-30
K103412 — AXIOM FASCIAL CLOSURE SYSTEMAxiom Technology Partners, LLC·Product code OCW·2010-12-30
K103668 — BNX FINE NEEDLE ASPIRATION SYSTEMBoston Endoscopic Engineering·Product code FCG·2010-12-30
K102279 — INCU IAtom Medical Corporation·Product code FMZ·2010-12-29
K103097 — INFRARED EAR THERMOMETERRadiant Innovation, Inc.·Product code FLL·2010-12-29
K103272 — ZENIUS SPINAL SYSTEMMedyssey Co, Ltd.·Product code MNI·2010-12-29
K103667 — SAPPHIRE ST PORTABLE DIODE LASERDen-Mat Holdings, LLC·Product code GEX·2010-12-29
K100993 — INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTSPrismatik Dentalcraft, Inc.·Product code NHA·2010-12-28
K101837 — ACL TIGHTROPE DOUBLE BUNDLEArthrex, Inc.·Product code HTY·2010-12-28
K102210 — LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLSLin-Zhi International, Inc.·Product code DKZ·2010-12-28
K102746 — MIRAGE FXResmed, Ltd.·Product code BZD·2010-12-28
K100932 — INCLUSIVE MINI IMPLANTPrismatik Dentalcraft, Inc.·Product code DZE·2010-12-27
K101294 — PT2 VARIAN PROTON THERAPY SYSTEMVarian Medical Systems, Oncology Systems·Product code LHN·2010-12-27
K102408 — DIGITAL DIAGNOSTIC X-RAY SYSTEMDRGEM Corporation·Product code KPR·2010-12-27
K102572 — IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KITSainath Intellectual Properties, LLC·Product code KNT·2010-12-27
K102595 — MEDISTIM VERIQC SYSTEMMedi-Stim Asa·Product code DPW·2010-12-27
K102835 — VITAL SIGNS MONITOREdan Instruments, Inc.·Product code DQA·2010-12-27
K102937 — OSTEOPHIL BETA-TCPCytophil, Inc.·Product code MQV·2010-12-27
K103193 — DOSEVIEW 3DStandard Imaging, Inc.·Product code IYE·2010-12-27
K103357 — LIFEBRIDGELifebridge Medizintechnik AG·Product code KFM·2010-12-27
K103359 — FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)C.R. Bard, Inc.·Product code KNW·2010-12-27
K103583 — DC-7 DIAGNOSTIC ULTRASOUND SYSTEMShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYN·2010-12-27

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