FDA 510(k) clearances — page 455

176,542 clearances on record, most recent first.

Clearances — page 455

45,401–45,500 of 176,542

K120735 — PATHASSIT LIGHT SEEKEREntellus Medical, Inc.·Product code LRC·2012-04-02
K120802 — ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWSWrightmedicaltechnologyinc·Product code HRS·2012-04-02
DEN110002 — SYSTEM 1E PROCESS BIOLOGICAL MONITORING KITSTERIS Corporation·Product code OVY·2012-03-30
K103834 — BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETSBio-Rad Laboratories·Product code MID·2012-03-30
K110019 — RESPIRATORY HUMIDIFERFisher & Paykel Healthcare, Ltd.·Product code BTT·2012-03-30
K111058 — URETRON MODEL URTMed-Sonics Corp.·Product code FFK·2012-03-30
K111549 — ATTUNE SLEEP APNEA SYSTEMApnicure, Inc.·Product code OZR·2012-03-30
K111664 — DIAZYME CYSTATIN C POC TEST KITDiazyme Laboratories·Product code NDY·2012-03-30
K112119 — CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACHWilliam Cook Europe Aps·Product code DTK·2012-03-30
K112351 — ULTRA BEAUTYJohari Digital Healthcare , Ltd.·Product code NFO·2012-03-30
K112452 — ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERSAngioDynamics, Inc.·Product code DQO·2012-03-30
K113168 — DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORICCiba Vision Corporation·Product code LPL·2012-03-30
K113431 — CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIABettini S.P.A.·Product code EIH·2012-03-30
K120145 — SIMPLE T NASAL MASKRespironics, Inc.·Product code BZD·2012-03-30
K120213 — ETCH-RITE SUPREMEPulpdent Corporation·Product code KLE·2012-03-30
K120221 — GE ECHOPACGE Healthcare·Product code LLZ·2012-03-30
K120273 — KITTYCAT CATHETER, KITTYCAT 2 CATHETERAvinger, Inc.·Product code PDU·2012-03-30
K120378 — PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA SKuraray Medical, Inc.·Product code EMA·2012-03-30
K120379 — PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA SKuraray Medical, Inc.·Product code EMA·2012-03-30
K120563 — KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BTMicrophage, Inc.·Product code OUS·2012-03-30
K120799 — ARISURE NEUTRAL VALVEYukon Medical, LLC·Product code FPA·2012-03-30
K110737 — RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700Bionime Corporation·Product code NBW·2012-03-29
K111703 — INFRARED EAR THEROMETERFudakang Industrial Co., Ltd.·Product code FLL·2012-03-29
K112538 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENTAlfa Wassermann Diagnostic Technologies, Inc.·Product code CHH·2012-03-29
K112702 — IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETSImperial Surgical , Ltd.·Product code LGZ·2012-03-29
K112798 — LOCKING COMPRESSION PLATE SYSTEMShanghai Microport Orthopedics Co., Ltd.·Product code HRS·2012-03-29
K112863 — ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONNActa Medical, LLC·Product code KNT·2012-03-29
K113058 — TIGER SPINE SYSTEMCorelink, LLC·Product code NKB·2012-03-29
K113233 — POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIMShen Wei (Usa), Inc.·Product code KGO·2012-03-29
K113288 — VPAP ST-AResmed, Ltd.·Product code MNS·2012-03-29
K113327 — HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEMStryker Corp.·Product code KTT·2012-03-29
K113365 — INFANT ARRAYAdvanced Imaging Research Dba Sree Medical Systems·Product code MOS·2012-03-29
K120005 — ACDSIsopure, Corp.·Product code KPO·2012-03-29
K120088 — MCOMPASS ANORECTAL MANOMETRY SYSTEMMedspira, LLC·Product code KLA·2012-03-29
K120206 — MEDTRONIC MINIMED PARADIGM INSULIN PUMPSMedtronic Minimed·Product code LZG·2012-03-29
K120568 — FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMAbbott Diabetes Care, Inc.·Product code NBW·2012-03-29
K120578 — ACCOLADE II HIP STEMHowmedica Osteonics·Product code JDI·2012-03-29
K120616 — SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390Spacelabs Medical, Inc.·Product code MHX·2012-03-29
K120627 — TOSHIBA 1.5T QD HEAD COILQuality Electrodynamics·Product code MOS·2012-03-29
K120738 — FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CMOstial Corporation·Product code LIT·2012-03-29
K120893 — IMAGER II ANGIOGRAPHIC CATHETERSBoston Scientific Corp·Product code DQO·2012-03-29
K103035 — SMARTPILOT VIEW MODEL MK04500Draeger Medical GmbH·Product code BSZ·2012-03-28
K110587 — CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)Bayer Healthcare, LLC·Product code LFR·2012-03-28
K110690 — ONE PERSONAL LUBRICANT (SILICONE)One·Product code NUC·2012-03-28
K110894 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METERBayer Healthcare·Product code LFR·2012-03-28
K112307 — RESIGLASS PASTEShofu Dental Corporation·Product code EMA·2012-03-28
K112422 — CRAG LATERAL FLOW ASSAY (LFA)Immuno-Mycologics, Inc.·Product code GMD·2012-03-28
K112774 — BD RECYKLEEN SHARPS COLLECTORSBecton, Dickinson and Company·Product code MMK·2012-03-28
K112834 — MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLESVerichem Laboratories, Inc.·Product code JIX·2012-03-28
K112948 — JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIRJiangsu Healthy Way Medical Equipment Co;Ltd·Product code IOR·2012-03-28
K112950 — JIANGSU HEALTHY WAY MECHANICL WHEELCHAIRJiangsu Healthy Medical Equipment Co;Ltd·Product code IOR·2012-03-28
K113243 — EM50 SELF MONITORING BLOOD GLUCOSE SYSTEMEps Bio Technology Corp.·Product code LFR·2012-03-28
K113324 — REXIOUS HOOK FIXATION SYSTEMSDio Medical Co., Ltd.·Product code KWP·2012-03-28
K113547 — GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GALApex BioTechnology Corp.·Product code CGA·2012-03-28
K113695 — ELLIPSE PRECICE TRAUMA NAIL SYSTEMEllipse Technologies, Inc.·Product code HSB·2012-03-28
K113702 — FOTONA XP ND: YAG LASER SYSTEMFotona D.D.·Product code PDZ·2012-03-28
K120123 — AQUASHIELD CO2 SYSTEMUnited States Endoscopy Group, Inc.·Product code FEQ·2012-03-28
K120576 — ZAVATION IBF SYSTEMZavation, LLC·Product code MAX·2012-03-28
K120630 — AZUR DETACHABLE 18MicroVention, Inc.·Product code KRD·2012-03-28
K111558 — SURGICASE GUIDEMaterialise NV·Product code HAW·2012-03-27
K112755 — ABACUS 5Diatron U.S., Inc.·Product code GKZ·2012-03-27
K112977 — MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)Alcon Research, Ltd.·Product code MSS·2012-03-27
K113247 — ANESTHESIA INJECTION TOOL SETKi Works Co., Ltd.·Product code EJI·2012-03-27
K113369 — ZIMMER PERSONA KNEE SYSTEMZimmer, Inc.·Product code JWH·2012-03-27
K113672 — PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMVATECH Co., Ltd.·Product code MUH·2012-03-27
K113815 — RESSCANResmed, Ltd.·Product code MNS·2012-03-27
K120061 — WOUND PROTECTORCovidien, Formerly US Surgical A Divison of Tyco H·Product code GCJ·2012-03-27
K120096 — MULTIFIX P KNOTLESS FIXATION DEVICEArthroCare Corporation·Product code MBI·2012-03-27
K120101 — INDEPENDENCE SPACERGlobus Medical, Inc.·Product code OVD·2012-03-27
K120416 — INSULATION TESTERSpectrum Surgical Supply Corp.·Product code GEI·2012-03-27
K120484 — VISIA ONCOLOGYMeVis Medical Solutions AG·Product code LLZ·2012-03-27
K120504 — LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAKBio-Rad Laboratories, Inc.·Product code DIF·2012-03-27
K120778 — BRIVO MR355Ge Hangwei Medical Systems Co., Ltd.·Product code LNH·2012-03-27
K110535 — ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTIONCarefusion 303, Inc.·Product code FRN·2012-03-26
K120270 — VENUS SPINAL FIXATION SYSTEML&K BIOMED Co., Ltd.·Product code NKB·2012-03-26
K120572 — BIOPLEX 2200 TORC IGGBio-Rad Laboratories, Inc.·Product code OMI·2012-03-26
K103704 — REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMPZephyr Sleep Technologies, Inc.·Product code LRK·2012-03-23
K110520 — BIOLIS 12ITokyo Boeki Medisys, Inc.·Product code CEM·2012-03-23
K111501 — I-LIPO SYSTEMChromogenex Technologies Limited·Product code OLI·2012-03-23
K112064 — RESORB X-GKLS-Martin L.P.·Product code JEY·2012-03-23
K112377 — BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZERShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code CFR·2012-03-23
K112469 — GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEMSonowand AS·Product code HAW·2012-03-23
K113304 — BLADDER SCANNERMEDA Co., Ltd.·Product code IYO·2012-03-23
K113733 — SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIXNeoortho Produtos Ortopedicos S/A·Product code HRS·2012-03-23
K113748 — IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)Imris, Inc.·Product code HBL·2012-03-23
K113866 — PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIXBrennen Medical, LLC·Product code KGN·2012-03-23
K120049 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+BBecton, Dickinson and Company·Product code PSZ·2012-03-23
K120538 — PALLS M SPINAL SYSTEMKorea Bone Bank Co., Ltd.·Product code MNI·2012-03-23
K120593 — MYOSURE CONTROL UNITHologic, Inc.·Product code HIH·2012-03-23
K120602 — APACERAM BONE GRAFT SUBSTITUTEHoya Corporation·Product code MQV·2012-03-23
K120743 — SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.·Product code HIB·2012-03-23
K111702 — AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPEFenwal, Inc.·Product code LKN·2012-03-22
K112478 — VISI MOBILE MONITORING SYSTEMSotera Wireless, Inc.·Product code MWI·2012-03-22
K112573 — EZSLEEP SLEEP QUALITY RECORDERPlatinum Team Co., Ltd.·Product code MWJ·2012-03-22
K113051 — SPACELABS ARKON ANESTHESIA WORKSTATIONSpacelabs Healthcare·Product code CBK·2012-03-22
K113117 — NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOXNihon Kohden America, Inc.·Product code GWQ·2012-03-22
K113220 — EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)Boston Scientific Corporation·Product code LOX·2012-03-22
K113265 — GENII GI 4000 ELECTROSUGICAL GENERATORGenii, Inc.·Product code GEI·2012-03-22
K113441 — PHYSIOLOGICAL MONITOR, PATIENT MONITORPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN·Product code MHX·2012-03-22
K113657 — INTELLIVUE PATIENT MONITORPhilips Medizin Systeme Boblingen GmbH·Product code MHX·2012-03-22

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