FDA 510(k) clearances — page 447

176,542 clearances on record, most recent first.

Clearances — page 447

44,601–44,700 of 176,542

K120372 — DR GREENBURGS HYBRID VACUUMAlways More Marketing, Inc.·Product code LRK·2012-06-27
K120760 — LDR SPINE SPINETUNE TL SPINAL SYSTEMLdr Spine USA, Inc.·Product code MNH·2012-06-27
K120780 — EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICEEdwards Lifesciences, LLC·Product code DWF·2012-06-27
K121016 — RANGE SPINAL SYSTEM (MESA AND DENALI)K2m, Inc.·Product code MNH·2012-06-27
K121049 — UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEMGlobus Medical, Inc.·Product code KWQ·2012-06-27
K121211 — VU APOD INTERVERTEBRAL BODY FUSION DEVICETheken Spine, LLC·Product code OVD·2012-06-27
K121274 — PIXEL APPGauss Surgical, Inc.,·Product code LWH·2012-06-27
K121295 — ARTISTETM SOLUTION WITH SYS VCIOSiemens Medical Solutions USA, Inc.·Product code IYE·2012-06-27
K121522 — POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)Polyremedy, Inc.·Product code FRO·2012-06-27
DEN120014 — VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)Nanosphere, Inc.·Product code PAM·2012-06-26
K111369 — THE HELENA V8 IMMUNODISPLACEMENT KITHelena Laboratories Uk, Ltd.·Product code CFF·2012-06-26
K113017 — SYS*STIM 240Mettler Electronics Corp.·Product code IPF·2012-06-26
K113383 — XTRAFIX EXTERNAL FIXATION SYSTEMExtraortho, Inc.·Product code KTT·2012-06-26
K120002 — I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLEBusse Hospital Disposables, Inc.·Product code KNW·2012-06-26
K120025 — SURGIMESH XB - SKIRTEDAspide Medical·Product code FTL·2012-06-26
K120632 — AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEMSTERIS Corporation·Product code MLR·2012-06-26
K120680 — ENSPIRE DISCECTOMY SYSTEMSpine View, Inc.·Product code HRX·2012-06-26
K121681 — GLIDER PTCA BALLOON CATHETERTrireme Medical, Inc.·Product code LOX·2012-06-26
K120134 — IPS E.MAX PRESS MULTIIvoclar Vivadent, AG·Product code EIH·2012-06-25
K120336 — NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR UHartalega Sdn Bhd·Product code LZC·2012-06-25
K121290 — AQUAMANTRYS3 BSC 9.1SMedtronic, Inc.·Product code GEI·2012-06-25
K112414 — ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYPhadia US, Inc.·Product code MSV·2012-06-22
K112805 — KIMGUARD ONE-STEP STERILIZATION WRAPKimberly-Clark Corp.·Product code FRG·2012-06-22
K112827 — SHEATHES ULTRASOND GELSheathing Technologies, Inc.·Product code MUI·2012-06-22
K112975 — CARBONAID C02 DIFFUSERCardia Innovation AB·Product code HIF·2012-06-22
K113873 — PENTAX EPK-I5020 VIDEO PROCESSORPentax of America, Inc.·Product code FET·2012-06-22
K120342 — EMG RECORDING ELECTRODE ASSEMBLYRhythmlink International, LLC·Product code IKT·2012-06-22
K120415 — CRYO-TOUCH IIIMyoscience, Inc.·Product code GXH·2012-06-22
K120472 — QUANTRAHologic, Inc.·Product code LLZ·2012-06-22
K120690 — INSULIN PEN NEEDLETiger Medical Products, Ltd.·Product code FMI·2012-06-22
K120959 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG KITBio-Rad Laboratories·Product code MXJ·2012-06-22
K120975 — CS 8100 CS 8100 ACCESSTrophy·Product code MUH·2012-06-22
K121018 — BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE ANSmith & Nephew, Inc.·Product code MBI·2012-06-22
K121222 — TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETERAbbott Vascular·Product code LOX·2012-06-22
K121342 — XIA 4.5 SPINAL SYSTEMStryker Corp.·Product code NKB·2012-06-22
K121459 — SYNGO.MR NEUROLOGYSiemens Medical Solutions USA, Inc.·Product code LLZ·2012-06-22
K121468 — EUROTROL GAS-ISE METABOLITESEurotrol B.V.·Product code JJY·2012-06-22
K121532 — HERO GRAFTHemosphere, Inc.·Product code DSY·2012-06-22
K121577 — APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEMToshiba Medical Systems Corporation, Japan·Product code IYN·2012-06-22
K121646 — ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc. Ultrasound Gro·Product code IYN·2012-06-22
K121699 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc.·Product code IYN·2012-06-22
K112824 — QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZERQuality Life Technologies Co;Ltd·Product code CAF·2012-06-21
K113277 — ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITSArrow International, Inc.·Product code LJS·2012-06-21
K113566 — OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUMLife Technologies, Inc.·Product code NDS·2012-06-21
K120245 — PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONSPlaytex, Inc.·Product code HIL·2012-06-21
K120247 — EASYDEXVineland Syrup, Inc.·Product code MRV·2012-06-21
K120339 — PROCOLLInnocoll Pharmaceuticals·Product code KGN·2012-06-21
K120524 — SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEMMui Scientific·Product code FFX·2012-06-21
K121028 — ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))Etview , Ltd.·Product code BTR·2012-06-21
K121031 — WAVELIGHT FS200 PATIENT INTERFACE 1505Alcon Research, Ltd.·Product code GEX·2012-06-21
K121032 — PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHPHospira, Inc.·Product code FPA·2012-06-21
K121165 — BEAM BRUSH/BEAM APPBeam Technologies, LLC·Product code EFW·2012-06-21
K121367 — ZOLL PROPAQ XMZOLL Medical Corporation·Product code MHX·2012-06-21
K121378 — AIRTRAQ SP AIRTRAQ AVANTProdol Meditec , Ltd.·Product code CCW·2012-06-21
K121521 — AXERA ACCESS SYSTEMArstasis, Inc.·Product code DYB·2012-06-21
K121675 — VERSAVITSynergetics, Inc.·Product code HQE·2012-06-21
K112024 — TI-MAX X450Nakanishi, Inc.·Product code EFB·2012-06-20
K112809 — BLUE MOUNTAIN CERVICAL PLATEQualgenix, LLC·Product code KWQ·2012-06-20
K113310 — ENDOGATER AVANTAGE CO2 INSUFFLATORByrne Medical, Inc.·Product code FCX·2012-06-20
K120048 — DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS SDrfp , Ltd.·Product code KIF·2012-06-20
K120418 — ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIESOlympus Winter & Ibe GmbH·Product code FAS·2012-06-20
K120447 — X4Advanced Brain Monitoring, Inc.·Product code OMC·2012-06-20
K120567 — GYRUS AMCI PK BUTTON ELECTRODEGyrus Acmi, Inc.·Product code FAS·2012-06-20
K120702 — E.G. SCAN II ESPHAGOSCOPE SYSTEMIntromedic Co., Ltd.·Product code EOX·2012-06-20
K120783 — ABLE-XIm-Able, Ltd.·Product code ION·2012-06-20
K120877 — MICROMANIPULATOR SETNarishige Co., Ltd.·Product code MQJ·2012-06-20
K120916 — QFIX RADIOTHERAPY CHAIRWfr/Aquaplast Corp.·Product code JAI·2012-06-20
K121403 — CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SETTeleflex, Inc.·Product code CAZ·2012-06-20
K121493 — ASCEND SHOULDER SYSTEMTornier, Inc.·Product code KWS·2012-06-20
K121530 — BODYFIX SYSTEMMedical Intelligence Medizintechnik GmbH·Product code IYE·2012-06-20
K121534 — CONE-TROL HEMOGLOBIN A1C CONTROL SETCone Bioproducts·Product code JJX·2012-06-20
K121588 — RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3Randox Laboratories, Ltd.·Product code JJX·2012-06-20
K112030 — SYNTHES RADIAL HEAD PROSTHESIS SYSTEMSynthes USA, LLC·Product code KWI·2012-06-19
K112508 — I-ROOT 100S-Denti Co., Ltd.·Product code LQY·2012-06-19
K112817 — MICROEEG SYSTEMBio-Signal Group Corporation·Product code GWQ·2012-06-19
K113033 — SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3MLNephron Pharmaceuticals Corp.·Product code CAF·2012-06-19
K113668 — HEALITE II SYSTEMLutronic Corporation·Product code ILY·2012-06-19
K120286 — TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANTChurch & Dwight Co., Inc.·Product code HIS·2012-06-19
K121024 — LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8Encore Medical L.P.·Product code LPH·2012-06-19
K121250 — OP SPINE SYSTEMOrthoPediatrics Corp.·Product code OSH·2012-06-19
K112184 — CIRRUS PHOTOCarl Zeiss Meditec, Inc.·Product code OBO·2012-06-18
K112763 — MATRIXBRUSH ENDOMETRIAL SAMPLERPost Oak Innovations, Inc.·Product code HFE·2012-06-18
K120159 — BEAUTICEM SAShofu Dental Corporation·Product code EMA·2012-06-18
K120503 — CMI IMPLANT IS II ACTIVENeobiotech Co., Ltd.·Product code DZE·2012-06-18
K120527 — ALPHA ORTHOPAEDICS AT2 SYSTEMAlpha Orthopaedics, Inc.·Product code GEI·2012-06-18
K120854 — SYNTHES VA LCP ANKLE TRAUMA SYSTEMSynthes USA·Product code HRS·2012-06-18
K120910 — CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEALGE Medical Systems SCS·Product code JAK·2012-06-18
K111863 — SIGNATURE PLANNER,SIGNATURE GUIDESMaterialise NV·Product code JDI·2012-06-15
K112742 — AUDIT MICROLQ SPINAL FLUID CONTROLAalto Scientific, Ltd.·Product code JJY·2012-06-15
K112754 — IVENT101Versamed Medical Systems , Ltd.·Product code CBK·2012-06-15
K113456 — READY VIEWGe Healthcare (Ge Medical Systems Scs)·Product code LLZ·2012-06-15
K113613 — DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEMShantou Institute of Ultrasonic Instuments·Product code IYN·2012-06-15
K120203 — TM-400 DEVICEZimmer Trabecular Metal Technology, Inc.·Product code MAX·2012-06-15
K120600 — DURAGEN SECURE DURAL REGNERATION MATRIXIntegra Life Sciences·Product code GXQ·2012-06-15
K120823 — BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORSFresenius Medical Care North America, Design Cente·Product code FJK·2012-06-15
K120870 — GREENLIGHT MOXY FIBER OPTICAmerican Medical Systems·Product code GEX·2012-06-15
K120912 — INFINITI(R) VISION SYSTEMAlcon Manufacturing, Ltd.·Product code HQC·2012-06-15
K121118 — FORA COMFORTSCAN EAR THERMOMETERForacare, Inc.·Product code FLL·2012-06-15
K121130 — POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODSBiomet Spine·Product code NKB·2012-06-15
K121246 — MEDYSSY LT CAGE SYSTEMMedyssey Co, Ltd.·Product code MAX·2012-06-15

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