FDA 510(k) clearances — page 428

176,542 clearances on record, most recent first.

Clearances — page 428

42,701–42,800 of 176,542

K130132 — BABYLANCE HEEL INCISION DEVICEMedipurpose Pte. , Ltd.·Product code FMK·2013-02-11
K112616 — NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESISHeinz Kurz GmbH Medizintechnik·Product code ETB·2013-02-08
K113268 — ALEXIS O WOUND PROTECTOR/RETRACTORApplied Medical Resources Corp.·Product code KGW·2013-02-08
K121280 — MYOSURE INTRUMENT TRAYHologic, Inc.·Product code KCT·2013-02-08
K121565 — UNI-GOLD CRYPTOSPORIDIUMTrinity Biotech·Product code MHJ·2013-02-08
K121942 — ADENOVIRUS R-GENE USArgene SA·Product code OCC·2013-02-08
K122065 — DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USEOrmco Corp.·Product code NOF·2013-02-08
K122386 — VICTUS FEMTOSECOND LASER PLATFORMTechnolas Perfect Vision GmbH·Product code OOE·2013-02-08
K122810 — COMPACT DIGITAL BLOOD PRESSURE MONITORThermor , Ltd.·Product code DXN·2013-02-08
K123023 — SURGERY REHEARSAL PLATFORMSurgical Theater, LLC·Product code LLZ·2013-02-08
K123131 — ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AITosoh Bioscience, Inc.·Product code MRG·2013-02-08
K123249 — DIAGNOSTIC ULTRASOUND SYSTEMEdan Instruments, Inc.·Product code IYN·2013-02-08
K123308 — PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEMAlbahealth, LLC·Product code JOW·2013-02-08
K123488 — LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREEPuyang Linshi Health Co., Ltd.·Product code LZA·2013-02-08
K123596 — OPTIMA CT520Ge Hangwei Medical Systems Co., Ltd.·Product code JAK·2013-02-08
K123688 — PROFEMUR TL CLASSIC HIP STEMWrightmedicaltechnologyinc·Product code LZO·2013-02-08
K123799 — PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIRPsychemedics Corp.·Product code DJG·2013-02-08
K130070 — 4MP COLOR LCD MONITOR, RADIFORCE RX440Eizo Nanao Corporation·Product code LLZ·2013-02-08
K130103 — CORONIS FUSION 6MPBarco N.V.·Product code LLZ·2013-02-08
K120558 — ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATIONLifescan, Inc.·Product code NBW·2013-02-07
K120701 — M2 WRIST MRI SYSTEMAspect Imaging, Ltd.·Product code LNH·2013-02-07
K120708 — ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEMCilag GmbH International·Product code NBW·2013-02-07
K120922 — GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNITSelectivemed Components, Inc.·Product code IPF·2013-02-07
K121050 — 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGEBecton, Dickinson & CO·Product code NGT·2013-02-07
K121818 — OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICEOxford Performance Materials·Product code GXN·2013-02-07
K122554 — GENASIS SCANVIEW SYSTEMApplied Spectral Imaging , Ltd.·Product code NTH·2013-02-07
K122587 — BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208St Jude Medical·Product code DRC·2013-02-07
K122633 — TOXCUP DRUG SCREEN CUPBranan Medical Corp.·Product code LDJ·2013-02-07
K122822 — SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEMSpectrum Spine, LLC·Product code NQW·2013-02-07
K122871 — COMPRESSYN STAPLEDallen Medical, Inc.·Product code JDR·2013-02-07
K123206 — MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEMMaxim Surgical·Product code ODP·2013-02-07
K123216 — AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE ANAimago SA·Product code DPT·2013-02-07
K123232 — SPINEOLOGY SPINOUS PROCESS PLATESpineology, Inc.·Product code KWP·2013-02-07
K123521 — RELIANCE SPINAL SCREW SYSTEMReliance Medical Systems, LLC·Product code MNI·2013-02-07
K123969 — XIPHOSDifusion Technologies·Product code MAX·2013-02-07
K130057 — ESPINNlt Spine, Ltd.·Product code HRX·2013-02-07
K121409 — ASAHI REXEED-SX/LX SERIES DIALYZERAsahi Kasei Medical Co., Ltd.·Product code KDI·2013-02-06
K122718 — BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREPBecton, Dickinson and Company·Product code GTY·2013-02-06
K122879 — EEGER4 MODEL 4.3Eeg Software, LLC·Product code HCC·2013-02-06
K123125 — GE DATEX-OHMEDA AVANCE CS2Datex-Ohmeda, Inc.·Product code BSZ·2013-02-06
K123326 — SHERPA PAK CARDIAC TRANSPORT SYSTEMParagonix Technologies, Inc.·Product code MSB·2013-02-06
K123460 — TRC-NW300 NON-MYDRIATIC RETINAL CAMERATopcon Medical Systems, Inc.·Product code HKI·2013-02-06
K123865 — VISUAL-ICE CRYOABLATION SYSTEMGalil Medical, Inc.·Product code GEH·2013-02-06
K123970 — CAAS INTRAVASCULARPie Medical Imaging BV·Product code LLZ·2013-02-06
K123992 — APLIO 500/400/300 V3.0Toshibamedical Systems Corporation·Product code IYN·2013-02-06
K130041 — SHEATHES STERILE ULTRASOUND GELSheathing Technologies, Inc.·Product code MUI·2013-02-06
K121453 — A-GRIX TE RESORABLE BONE VOID FILLERAg Digital Technology Corp.·Product code MQV·2013-02-05
K122183 — AUGMENT AND SCREW, PSA TYPEUnited Orthopedic Corp.·Product code JWH·2013-02-05
K122520 — DIGITAL THERMOMTERTaidoc Technology Corporation·Product code FLL·2013-02-05
K122781 — RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOADCovidien, Formerly US Surgical A Divison of Tyco H·Product code GDW·2013-02-05
K122805 — PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHORParcus Medical, LLC·Product code MBI·2013-02-05
K123050 — EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)Nantong Biotechnology Co., Ltd.·Product code LCX·2013-02-05
K123114 — ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICEETHICON, Inc.·Product code GDW·2013-02-05
K123138 — PASS LP SPINAL SYSTEMMedicrea International·Product code OSH·2013-02-05
K123215 — VISCOSTAT CLEARUltradent Products, Inc.·Product code MVL·2013-02-05
K123217 — CARDEASCREENCardea Associates, Inc.·Product code DPS·2013-02-05
K123309 — GIRAFFE AND PANDA WARMERSOhmeda Medical·Product code FMT·2013-02-05
K123434 — PROFEMUR Z CLASSIC STEMSWrightmedicaltechnologyinc·Product code LZO·2013-02-05
K130016 — LIFESPAN EPTFE VASCULAR GRAFTLeMaitre Vascular, Inc.·Product code DSY·2013-02-05
K120804 — CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEMCianna Medical·Product code PBY·2013-02-04
K122046 — WRIST PULSE OXIMETERBeijing Choice Electronic Technololgy Co., Ltd.·Product code DQA·2013-02-04
K123170 — VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies America·Product code KNY·2013-02-04
K123704 — AUTOMATED ENDOSCOPE LEAK TESTEROlympus Medical Systems Corp.·Product code PCV·2013-02-04
K111275 — CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARESmiths Medical Asd, Inc.·Product code FRN·2013-02-01
K113504 — DEKA SMARTXIDE AND DELIVERY ACCESSORIESEl.En Electronic Engineering Spa·Product code GEX·2013-02-01
K121327 — DIOLASE 10SBiolase Technology, Inc.·Product code GEX·2013-02-01
K121418 — PLANMED VERITYPlanmed OY·Product code JAK·2013-02-01
K121456 — AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROLArkray, Inc.·Product code KQO·2013-02-01
K121985 — ARCHITECT TOTAL BILIRUBINAbbott Laboratories·Product code CIG·2013-02-01
K122081 — NUVASIVE LONG LATERAL SPINAL SYSTEMNuvasive, Inc.·Product code KWQ·2013-02-01
K122159 — DORNIER MEDILAS H30 SOLVODornier Medtech America, Inc.·Product code GEX·2013-02-01
K122550 — ICS IMPULSEGn Otometrics·Product code GWN·2013-02-01
K122853 — NOVEL FIT AND FILL STEMHowmedica Osteonics Corp.·Product code MEH·2013-02-01
K122865 — VIVIX-S WIRELESSVieworks Co., Ltd.·Product code MQB·2013-02-01
K123033 — ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE BRocket Medical Plc·Product code DWM·2013-02-01
K123134 — EASYSPINE SYSTEMLdr Spine USA, Inc.·Product code NKB·2013-02-01
K123362 — MILAGRO ADVANCE INTERFERENCE SCREWDepuy Mitek, A Johnson & Johnson Company·Product code HWC·2013-02-01
K123420 — SYNGO, BREAST CARESiemens Medical Solutions USA, Inc.·Product code LLZ·2013-02-01
K123519 — INVIVO DENTALAnatomage, Inc.·Product code LLZ·2013-02-01
K123538 — EPIEN ROOT CANAL CLEANSEREpien Medical, Inc.·Product code KJJ·2013-02-01
K123545 — INCORIS TZISirona Dental Systems GmbH·Product code EIH·2013-02-01
K123578 — ANTERIOR CERVICAL PLATE SYSTEMWeigao Orthopaedic Device Co., Ltd.·Product code KWQ·2013-02-01
K123610 — E-CUBE 15Alpinion Medical Systems Co., Ltd.·Product code IYN·2013-02-01
K123757 — POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLORAssurguard Sdn. Bhd.·Product code LYY·2013-02-01
K123995 — MICRODOSE SIPhilips Digital Mammography Sweden AB·Product code MUE·2013-02-01
K112880 — CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPEFreedom Meditech, Inc.·Product code MYC·2013-01-31
K113353 — GEMINI STERILZATION WRAPMedline Industries, Inc.·Product code FRG·2013-01-31
K113530 — ULTRASONIC SCALERNakanishi, Inc.·Product code ELC·2013-01-31
K122396 — POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Wealth on (Jiangsu) Co., Ltd.·Product code LYZ·2013-01-31
K122696 — POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)Cardinal Health, Inc.·Product code LZA·2013-01-31
K123111 — V8 TRANSLUMINAL BAV CATHETERIntervalve, Inc.·Product code OZT·2013-01-31
K123196 — PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATHCovidien·Product code MSD·2013-01-31
K123258 — THE ADVANCE CATHETER FOR HSG AND SISCatheter Research, Inc.·Product code LKF·2013-01-31
K123397 — MULTILINK AUTOMIXIvoclar Vivadent, AG·Product code EBF·2013-01-31
K123691 — MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)Medtronic Sofamor Danek, Inc.·Product code MQV·2013-01-31
K123764 — DURETTE OCULAR IMPLANTOculo-Plastik, Inc.·Product code HPZ·2013-01-31
K123775 — LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAKBio-Rad Laboratories·Product code JJY·2013-01-31
K130013 — X4 SYSTEMAdvanced Brain Monitoring, Inc.·Product code OMC·2013-01-31
K113816 — GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SVGC America, Inc.·Product code NHA·2013-01-30
K122300 — T3 DENTAL IMPLANTBiomet 3i·Product code DZE·2013-01-30

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