FDA 510(k) clearances — page 459

176,542 clearances on record, most recent first.

Clearances — page 459

45,801–45,900 of 176,542

K111938 — IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...Immunodiagnostic Systems , Ltd.·Product code JJX·2012-02-14
K113390 — LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)Meridian AG·Product code GEX·2012-02-14
K113403 — GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEMGE Medical Systems SCS·Product code OWB·2012-02-14
K113496 — VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KITColoplast A/S·Product code OTM·2012-02-14
K113551 — ESOPHAGEAL TTS STENTTaewoong Medical Co., Ltd.·Product code ESW·2012-02-14
K113634 — INJEKT CYSTO FLEXIBLE INJECTION NEEDLECook Ireland, Ltd.·Product code FBK·2012-02-14
K113710 — DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLORFull Synergy Medical Products, Inc.·Product code LYZ·2012-02-14
K113722 — DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLORFull Synergy Medical Products, Inc.·Product code LYZ·2012-02-14
K120132 — SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITORPhilips Medical Systems·Product code DXN·2012-02-14
K120137 — VICTORY GUIDEWIRE (32 MODELS)Brivant, Ltd.·Product code DQX·2012-02-14
K120144 — VITAL SIGNS MONITOREdan Instruments, Inc.·Product code DXN·2012-02-14
K111405 — BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,Hangzhou Bever Medical Devices Co., Ltd.·Product code GBM·2012-02-13
K112595 — COFLEX-FParadigm Spine, LLC·Product code KWP·2012-02-13
K113406 — AQUASIL ULTRA SMART WETTING IMPRESSION MATERIALDentsply International, Inc.·Product code ELW·2012-02-13
K103044 — AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTIONBestgen Biotech Corp.·Product code NBW·2012-02-10
K110078 — EXTRICAREDevon Medical Products, Inc.·Product code OMP·2012-02-10
K110623 — PILLAR PALATAL IMPLANT SYSTEMMedtronic Xomed, Inc.·Product code LRK·2012-02-10
K112016 — L-SER KO LAMPYa-Man, Ltd.·Product code ILY·2012-02-10
K112042 — KINGYIELD WRIST BLOOD PRESSURE MONITORShenzhen Kingyield Technology Co., Ltd.·Product code DXN·2012-02-10
K112888 — MESO WOUND MATRIXKensey Nash Corporation·Product code KGN·2012-02-10
K112994 — CRE DITATATION BALLONBoston Scientific Corporation·Product code FGE·2012-02-10
K113259 — NOTOUCH BREASTSCANUe Lifesciences, Inc.·Product code LHQ·2012-02-10
K113305 — VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLEbioMerieux, Inc.·Product code LON·2012-02-10
K113362 — SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)Spine View, Inc.·Product code HRX·2012-02-10
K113542 — SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)Salter Labs, Arvin Facility·Product code BTT·2012-02-10
K113612 — AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00APanasonic Healthcare Co., Ltd.·Product code IYN·2012-02-10
K113697 — EIGR SURGICAL ILLUMINATION SYSTEMInvuity, Inc.·Product code FST·2012-02-10
K120122 — SENSE MSK S 8CH 1.5TInvivo Corporation·Product code MOS·2012-02-10
K120131 — REGIUS SIGMA2Konica Minolta Medical & Graphic, Inc.·Product code MQB·2012-02-10
K120268 — AMID STAPLERSafestich Medical, LLC·Product code GDW·2012-02-10
K111467 — FLEXI-Q DV AND DVR AUTO-INJECTORSElcam Medical Acal·Product code KZH·2012-02-09
K112006 — HAMILTON-TC1Hamilton Medical AG·Product code CBK·2012-02-09
K112407 — SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERSSmiths Medical MD, Inc.·Product code DYB·2012-02-09
K112709 — STIMULATION/DISSECTION INSTRUMENTSNu Vasive, Incorporated·Product code ETN·2012-02-09
K113104 — INTEGRA WOUND MATRIX (THIN)Integra LifeSciences Corporation·Product code KGN·2012-02-09
K113183 — PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500Shanghai 3f Electronics Co, Ltd.·Product code MWI·2012-02-09
K113250 — DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBEDynatronics Corp.·Product code ILY·2012-02-09
K113529 — CD HORIZON VOYAGER SPINAL SYSTEMMedtronic Sofamor Danek·Product code NKB·2012-02-09
K113772 — HPR EMOLLIENT FOAMPrugen IP Holdings, Inc.·Product code FRO·2012-02-09
K113774 — HPR PLUS EMOLLIENT FOAMPrugen IP Holdings, Inc.·Product code FRO·2012-02-09
K120212 — AFX INTRODUCER SYSTEMEndologix, Inc.·Product code DYB·2012-02-09
K103726 — JARIT TAKE-APART ENDOSCOPIC INSTRUMENTSIntegra LifeSciences Corporation·Product code KNF·2012-02-08
K111249 — ORTHOSLENDERIZEROrthomatics, Inc.·Product code EFB·2012-02-08
K111937 — CLEARFLASH AC2100 COSMETIC SYSTEMClearflash Technologies, Inc.·Product code OLP·2012-02-08
K112542 — YOMURA SAFETY I.V. CATHETERYomura Technologies, Inc.·Product code FOZ·2012-02-08
K112723 — EPIGRAYDosisoft SA·Product code MUJ·2012-02-08
K113343 — DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEMDelbio Incorporation·Product code NBW·2012-02-08
K113396 — DEPUY PULSE THORACOLUMBAR SCREW SYSTEMMedos International SARL·Product code NKB·2012-02-08
K113426 — VERACIA SAShofu Dental Corporation·Product code ELM·2012-02-08
K113600 — IM BANDSynexmed(Shenzhen)Company Limited·Product code DXC·2012-02-08
K120083 — SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)Synthes USA·Product code HSB·2012-02-08
K120156 — PUREIMAGE ULTRASOUND TRANSMISSION GELMedline·Product code ITX·2012-02-08
K120178 — WINGMAN EXTENDABLE TIP SUPPORT CATHETERReflow Medical·Product code DQY·2012-02-08
K111678 — ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESISOrtho Solutions Limited·Product code HRS·2012-02-07
K112383 — CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLERSkeletal Kinetics, LLC·Product code MQV·2012-02-07
K112541 — Z FLEX-270TM STEERABLE SHEATHGreat Batch Medical·Product code DRA·2012-02-07
K112591 — SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORSSafe Secure Packaging Co., Ltd.·Product code FRG·2012-02-07
K112673 — PROPHY-MATE NEONakanishi, Inc.·Product code EFB·2012-02-07
K113021 — TRUFREEZE SYSTEM, TRUFREEZE SPRAY KITCSA Medical, Inc.·Product code GEH·2012-02-07
K113214 — TLINK DATA MANAGEMENT SYSTEM (DMS)Terumo Cardiovascular Systems Corp.·Product code DXJ·2012-02-07
K113360 — MEDICAL IMAGE PROCESSING UNITHumanray Co,Ltd·Product code EAP·2012-02-07
K113401 — ORTHO-1(NOT FINALIZED)Bisco, Inc.·Product code DYH·2012-02-07
K111481 — CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERSCorin USA·Product code OQI·2012-02-06
K111726 — PATHWAY AVIDCustom Spine, Inc.·Product code MAX·2012-02-06
K111890 — FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation·Product code NBW·2012-02-06
K111959 — AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVEAesculap, Inc.·Product code MPN·2012-02-06
K112106 — NAVIAID ICVI-F,S,B,R DEVICESmart Medical Systems , Ltd.·Product code ODC·2012-02-06
K112642 — AQUILEX FLUID CONTROL SYSTEM H112W.O.M. World of Medicine AG·Product code HIG·2012-02-06
K113100 — POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSMaxter Glove Manufacturing Sdn Bhd·Product code LZA·2012-02-06
K113196 — VASCULAR SONOPAJUNK GmbH Medizintechnologie·Product code DYB·2012-02-06
K113319 — ROTOR-GENE Q MDXQIAGEN GmbH·Product code OOI·2012-02-06
K113323 — ARTUS INFL A/B RG RT-PCR KITQIAGEN GmbH·Product code OCC·2012-02-06
K113642 — PERIMETER INTERBODY FUSION DEVICEMedtronic Sofamor Danek USA·Product code MAX·2012-02-06
K113653 — PATIENT MONITOREdan Instruments, Inc.·Product code MHX·2012-02-06
K113716 — ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIREAsahi Intecc Co., Ltd.·Product code DQX·2012-02-06
K113752 — METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SETSolana Surgical, LLC·Product code KWD·2012-02-06
K113762 — CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEMArthrosurface, Inc.·Product code HRS·2012-02-06
K113862 — ZIO PATCHiRhythm Technologies, Inc.·Product code DSH·2012-02-06
K120029 — HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SETSolana Surgical, LLC·Product code KWD·2012-02-06
K103325 — IDS-ISYS INTACT PTHImmunodiagnostic Systems , Ltd.·Product code CEW·2012-02-03
K110550 — BRIGHT EMBRACE MODEL SBL60Physician Engineered Products, Inc.·Product code LBI·2012-02-03
K111684 — PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELDPlaytex Manufacturing, Inc.·Product code HIL·2012-02-03
K112099 — CONTOUR HEALERContour Healer, LLC·Product code NHA·2012-02-03
K112188 — PIEZOTOME SOLOSatelec - Acteon, Inc.·Product code DZI·2012-02-03
K112540 — S-MINI IMPLANT SYSTEMNeobiotech Co., Ltd.·Product code DZE·2012-02-03
K112953 — TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICSTeratech Corp.·Product code IYN·2012-02-03
K113322 — CONSERVE THIN SHELLWrightmedicaltechnologyinc·Product code KWA·2012-02-03
K113334 — AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETSOpal Orthodontics by Ultradent Products, Inc.·Product code NJM·2012-02-03
K113359 — CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBEChison Medical Imaging Co., Ltd.·Product code IYN·2012-02-03
K120047 — CORAL SPINAL SYSTEMTheken Spine, LLC·Product code NKB·2012-02-03
K120068 — CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)Conformis, Inc.·Product code JWH·2012-02-03
K120103 — REST ASSURED GENERATION III DENTAL PROTECTORRanir, LLC·Product code OBR·2012-02-03
K120129 — MANTARAY CATHETERBridgepoint Medical·Product code DQY·2012-02-03
K110051 — RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KITGreat Batch Medical·Product code DYB·2012-02-02
K112976 — NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATMHartalega Snd. Bhd.·Product code LZA·2012-02-02
K113074 — CMAP PROMedical Technologies, Inc.·Product code IKN·2012-02-02
K113165 — MINI-MEDICAthena Gtx·Product code MWI·2012-02-02
K113197 — APC FLASH-FREE ADHESIVE3M Unitek Corporation·Product code DYH·2012-02-02
K120006 — HERO GRAFTHemosphere, Inc.·Product code DSY·2012-02-02
K120017 — FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEMFresenius Medical Care North America·Product code KDI·2012-02-02

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