FDA 510(k) clearances — page 457

176,542 clearances on record, most recent first.

Clearances — page 457

45,601–45,700 of 176,542

K113487 — HEMO-CATH 10F, HEMO-CATH 12.5FMedical Components, Inc.·Product code MSD·2012-03-09
K120233 — SYNCHRONY RESPIRATORY TRACKING SYSTEMAccuray Incorporated·Product code IYE·2012-03-09
K120380 — SATURN 8000New Medical Co., Ltd.·Product code MQB·2012-03-09
K120399 — LANX SPINAL FIXATION SYSTEMLanx, LLC·Product code NKB·2012-03-09
K120525 — QLAB QUANTIFICATION SOFTWAREPhilips Healthcare Group·Product code LLZ·2012-03-09
K113082 — SONOVISIONPeridot Technologies Ny, Inc.·Product code LLZ·2012-03-08
K113131 — LIASYS 450Ams·Product code CFR·2012-03-08
K113151 — IFS LASER SYSTEMAbbott Medical Optics, Inc.·Product code GEX·2012-03-08
K113810 — MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULESAlma Lasers, Inc.·Product code PDZ·2012-03-08
K113822 — QUADRASPHERE 30 TO 60Biosphere Medical, Inc.·Product code HCG·2012-03-08
K113872 — THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACAREVidacare Corporation·Product code KNW·2012-03-08
K120044 — ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELEDArthrex, Inc.·Product code KWS·2012-03-08
K120434 — POWER ADAPTOR INSTRUMENT ACCESSORYStryker Corp.·Product code NKB·2012-03-08
K120526 — YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIRJiangsu Yuyue Medical Equipment & Supply Co., Ltd.·Product code IOR·2012-03-08
K113255 — PUREGRAFT 850/PURE SYSTEMCytori Therapeutics, Inc.·Product code MUU·2012-03-07
K113284 — BIOPSY POSITIONERFuji Film Medical Systems·Product code IZH·2012-03-07
K113372 — NUVANT, MOBILC CARDIAC TELEMETRYCorventis, Inc.·Product code QYX·2012-03-07
K113575 — HILLA DIGITAL TRANSFERSHilla Technologies, Inc.·Product code EIH·2012-03-07
K113807 — DEXERYL CREAMPierre Fabre Medical Devices·Product code FRO·2012-03-07
K120109 — SUPER SEAL TOOTH DESENSITIZERPhoenix Dental, Inc.·Product code LBH·2012-03-07
K120355 — LEUCADIA 4.5 MM PEDICLE SCREW SYSTEMPhygen, LLC·Product code NKB·2012-03-07
K111268 — CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEMBayer Healthcare·Product code LFR·2012-03-06
K112547 — NEO NESTDenovo Proucts, LLC·Product code IMD·2012-03-06
K112606 — ACTIVATOR V-EActivator Methods International, Ltd.·Product code LXM·2012-03-06
K113274 — FOOTPRINT ULTRA PK SUTURE ANCHORSmith & Nephew, Inc.·Product code MBI·2012-03-06
K113356 — HOLOGIC VISCERAL FAT SOFTWAREHologic, Inc.·Product code KGI·2012-03-06
K113464 — NC TREK OTW CORONARY DILATATION CATHETERAbbott Vascular·Product code LOX·2012-03-06
K113686 — KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATEDMayer Laboratories, Inc.·Product code HIS·2012-03-06
K113790 — DISPOSABLE VINYL EXAM GLOVE, POWDEREDFull Synergy Medical Products, Inc.·Product code LYZ·2012-03-06
K113832 — SONICEYE ULTRASOUND TRANSDUCERBlacktoe Medical Iii, Inc.·Product code ITX·2012-03-06
K120124 — FORESIGHT U120 URINE ANALYZERACON Laboratories, Inc.·Product code JIL·2012-03-06
K120254 — THERASAGE HEATING PADTherasage Corporation·Product code ILY·2012-03-06
K120318 — VIVI ERGON-X HFVivi S.R.L.·Product code MUH·2012-03-06
K120358 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Hongxin Plastic Products Co., Ltd.·Product code LYZ·2012-03-06
K120505 — FRESENIUS 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America, Design Cente·Product code KDI·2012-03-06
K110901 — SYMBIQ INFUSION AND ADMINSTRATION SETHospira, Inc.·Product code FRN·2012-03-05
K111792 — MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINISignus Medizintechnik GmbH·Product code MAX·2012-03-05
K111869 — VIRTUOSO SYSTEM FOR IHC PR (IE2)Ventana Medical Systems, Inc.·Product code NQN·2012-03-05
K113422 — TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLETerumo (Philippines) Corporation·Product code FMI·2012-03-05
K113478 — PLIF CAGEEisertech, LLC·Product code MAX·2012-03-05
K113655 — TI-MAX X TURBINENakanishi, Inc.·Product code EFB·2012-03-05
K113711 — LIME-LITE IIPulpdent Corporation·Product code EJK·2012-03-05
K113750 — DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLORFull Synergy Medical Products, Inc.·Product code LYZ·2012-03-05
K103081 — COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANEBiom'Up Sas·Product code JXI·2012-03-02
K110745 — HELICOBACTER PYLORI ELISA IGG TEST KITGold Standard Diagnostics·Product code LYR·2012-03-02
K111423 — CS 1600 INTRAORAL CAMERACarestream Health, Inc.·Product code NBL·2012-03-02
K111544 — GLIDER PTCA BALLOON CATHETERTrireme Medical, Inc.·Product code LOX·2012-03-02
K111670 — VENUS FREEZE (MP)2 SYSTEMVenus Concept , Ltd.·Product code GEI·2012-03-02
K111964 — AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITYAalto Scientific, Ltd.·Product code JJY·2012-03-02
K113095 — E-CARE INFRARED EAR THERMOMETERE-Care Technology Corporation·Product code FLL·2012-03-02
K113097 — LASER HELMETTheradome, Inc.·Product code OAP·2012-03-02
K113264 — ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)Ld Technology, LLC·Product code DXN·2012-03-02
K113297 — KNOTILUS ANCHOR SYSTEMT.A.G. Medical Products Corporation, Ltd.·Product code MBI·2012-03-02
K113455 — SOLITAIRE FR REVASCULARIZATION DEVICEMicro Therapeutics Dba Ev3 Neurovascular·Product code NRY·2012-03-02
K113584 — PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVERSt Jude Medical·Product code DXO·2012-03-02
K113594 — C-THV SYSTEMPaieon, Inc.·Product code IZI·2012-03-02
K113617 — SPEE-DEE PATCHPulpdent Corporation·Product code EBF·2012-03-02
K113784 — 3MP MONOCHROME LCD MONITOR, RADIFORCE GX340Eizo Nanao Corporation·Product code LLZ·2012-03-02
K113797 — DISPOSABLE VINYL EXAM GLOVE, POWDER FREEFull Synergy Medical Products, Inc.·Product code LYZ·2012-03-02
K120274 — DELTAMAXX 18 MICROCOIL SYSTEMCodman and Shurtleff, Inc.·Product code HCG·2012-03-02
K111426 — EUCLID (TM) TIER 1-GW ACCESS SYSTEMHouston Medical Robotics·Product code ITX·2012-03-01
K111654 — FD TENS 2070Fuji Dynamics , Ltd.·Product code GZJ·2012-03-01
K111841 — SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLEChengdu Xinjin Shifeng Med Appratus Inst Co., Ltd.·Product code FMF·2012-03-01
K111947 — DUET MAGNADirex Systems Corp.·Product code LNS·2012-03-01
K112133 — OASYS SURGICAL LIGHT CONTROLLEROasys Healthcare·Product code FTA·2012-03-01
K112507 — RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEMMako Surgical Corporation·Product code OLO·2012-03-01
K112568 — AONGEN DENTAL COLLAGEN MATRIXAeon Astron Europe B.V.·Product code OLR·2012-03-01
K112769 — CURAD COMPRESSION HOSIERYMedline Industries, Inc.·Product code DWL·2012-03-01
K113003 — ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...Astra Tech, Inc.·Product code NHA·2012-03-01
K113037 — PAIN-AIDPdi Works, LLC·Product code NUH·2012-03-01
K113188 — SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONGPAJUNK GmbH Medizintechnologie·Product code CAZ·2012-03-01
K113232 — MAXMIXING BLOCKMaxtec, Inc.·Product code BZR·2012-03-01
K113238 — FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITORHealth & Life Co., Ltd.·Product code DXN·2012-03-01
K113249 — TRANSPORT CULTURE MEDIUM DEVICEPuritan Medical Products, LLC·Product code JSM·2012-03-01
K113569 — APNEARXApnea Science Corporation·Product code LRK·2012-03-01
K120304 — FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETERFootprint Medical, Inc.·Product code FOS·2012-03-01
K111341 — CLEANE / CLEANE POPMedicon Co., Ltd.·Product code OZC·2012-02-29
K112815 — QUANTUM BARIATRIC 451Pride Mobility Product Corporration·Product code ITI·2012-02-29
K112891 — APEX REVISION KNEE SYSTEMSOmni Life Science, Inc.·Product code JWH·2012-02-29
K113207 — SONO TAP, TUOHY SONOPajunk GmbH·Product code BSP·2012-02-29
K113272 — INOMAX DS(DELIVERY SYSTEMSIno Therapeutics, LLC/Dba Ikaria·Product code MRN·2012-02-29
K113364 — 2.7MM LCP ULNA OSTEOTOMY SYSTEMSynthes (USA) Products, LLC·Product code HRS·2012-02-29
K113550 — VANGUARD COMPLETE KNEE SYSTEMBiomet Manufacturing Corp·Product code JWH·2012-02-29
K113828 — DYNANAIL ANKLE ARTHRODESIS NAILMedShape, Inc.·Product code HSB·2012-02-29
K120078 — HEALIX ADVANCE BR ANCHORDepuy Mitek Inc., Johnson and Johnson Company·Product code MAI·2012-02-29
K120258 — DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERSCovidien, Formerly US Surgical A Divison of Tyco H·Product code GDW·2012-02-29
K120293 — SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVESpineology, Inc.·Product code MAX·2012-02-29
K111456 — MEDISIGN BLOOD GLUCOSE MONITORING SYSTEMTianjin Empecs Medical Device Co., Ltd.·Product code NBW·2012-02-28
K111893 — VITEK(R) 2 STREPTOCOCCUS TETRACYCLINEbioMerieux, Inc.·Product code LON·2012-02-28
K113148 — E-PASSSynexmed(Shenzhen)Company Limited·Product code DTL·2012-02-28
K113202 — TISSUE MARKERFocal Therapeutics·Product code NEU·2012-02-28
K113346 — NEON SYSTEMUlrich GmbH & Co. KG·Product code KWP·2012-02-28
K120024 — MECTALIF TRANSFORAMINALMedacta International S.A.·Product code MAX·2012-02-28
K120067 — MOSAIQ ONCOLOGY INFORMATION SYSTEMImpac Medical Systems, Inc.·Product code IYE·2012-02-28
K120290 — TOSHIBA 1.5T CARDIAC COILQuality Electrodynamics·Product code MOS·2012-02-28
K103824 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUSThe Binding Site·Product code CFN·2012-02-27
K110821 — BARF BANDDoodlebug Products, LLC·Product code MVV·2012-02-27
K112807 — X-RAY VVAMedis Medical Imaging Systems BV·Product code LLZ·2012-02-27
K113007 — BIONIME DIABETES MANAGEMENT SYSTEM VI.0Bionime Corporation·Product code JQP·2012-02-27
K113231 — WARP10,WARP75Quantum Devices, Inc.·Product code ILY·2012-02-27

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