FDA 510(k) clearances — page 453

176,542 clearances on record, most recent first.

Clearances — page 453

45,201–45,300 of 176,542

K120231 — EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)Biolitec Medical Devices, Inc.·Product code GEX·2012-04-24
K120452 — FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEMFlexible Stenting Solutions, Inc.·Product code FGE·2012-04-24
K120589 — MILAGRO INTERFERENCE SCREWSDepuy Mitek, A Johnson & Johnson Company·Product code MAI·2012-04-24
K120645 — PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITIONWrightmedicaltechnologyinc·Product code HWC·2012-04-24
K120662 — PICCOLO HDL-CAPILLARY TEST SYSTEMAbaxis, Inc.·Product code JHM·2012-04-24
K120664 — PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEMAbaxis, Inc.·Product code JGY·2012-04-24
K120757 — SLEEPWEAVER ELAN NASAL CPAP MASKCircadiance, LLC·Product code BZD·2012-04-24
K121004 — APEX KIRSCHNER WIRES AND STEINMANN PINSApex Tools & Orthopedics Co.·Product code HTY·2012-04-24
K111824 — FLAT PANEL DETECTORCanon Inc. -Medical Equipment Group·Product code MQB·2012-04-23
K112315 — HOME PREGNANCY TESTNewscen Coast Bio-Pharmaceutical Co., Ltd.·Product code JHI·2012-04-23
K113857 — SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBESynergetics, Inc.·Product code HQB·2012-04-23
K120207 — VISIAMeVis Medical Solutions AG·Product code LLZ·2012-04-23
K111425 — OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190Olympus Medical Systems Corp.·Product code HET·2012-04-20
K112666 — SALINE WOUND WASHNanoplas, Inc.·Product code FRO·2012-04-20
K112795 — PALTOP DENTAL IMPLANT SYSTEMPaltop Advanced Dental Solutions, Ltd.·Product code DZE·2012-04-20
K112992 — EARLOGIC OAE TESTEREarlogic Corporation·Product code EWO·2012-04-20
K113240 — 3.7 MP COLOR LCD MONITOR, RADIFORCE MX270WEizo Nanao Corporation·Product code LLZ·2012-04-20
K113611 — RAPID PROGRAMMERSt Jude Medical·Product code GZB·2012-04-20
K113633 — MCKESSON ANESTHESIA CAREMckesson Technologies, Inc.·Product code BSZ·2012-04-20
K113662 — FENESTRATED NERVE BLOCK NEEDLEImd, Inc.·Product code CAZ·2012-04-20
K113719 — SAFETY SCREW CONNECTORAbbott Laboratories·Product code KNT·2012-04-20
K113778 — EXCELSIOR XT-27 MICROCATHETERStryker Neurovascular·Product code DQY·2012-04-20
K113780 — EASYCARE TX SYSTEM (CONNEXUNS)Resmed, Ltd.·Product code BZD·2012-04-20
K120037 — BLUWHITE DIAMOND DENTAL BURS MODIFIEDBeavers Dental, Div. Sybron Canada, Ltd.·Product code DZP·2012-04-20
K120051 — SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4MLNephron Pharmaceuticals Corp.·Product code CAF·2012-04-20
K120208 — CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBESMauna Kea Technologies·Product code OWN·2012-04-20
K120313 — NEO CR KNEE SYSTEMPipeline Orthopedics·Product code JWH·2012-04-20
K120428 — GORE DRYSEAL SHEATHW. L. Gore & Associates, Inc.·Product code DYB·2012-04-20
K120853 — NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,Bioness, Inc.·Product code GZI·2012-04-20
K120868 — MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETERDatascope Corp., Cardiac Assist Division·Product code DSP·2012-04-20
K120872 — ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPSUnomedical A/S Infusion Devices·Product code FPA·2012-04-20
K120942 — PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANCParcus Medical, LLC·Product code MBI·2012-04-20
K111464 — PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVESDipped Products (Thailand), Ltd.·Product code LZA·2012-04-19
K111872 — VIRTUOSO SYSTEM FOR IHC P53 (DO-7)Ventana Medical Systems, Inc.·Product code NQN·2012-04-19
K112286 — NOVAC 11New Radiant Technology S.P.A.·Product code IYE·2012-04-19
K112536 — SONICISION STERILIZATION TRAYCovidien·Product code KCT·2012-04-19
K112843 — PULSE OXIMETERNonin Medical, Inc.·Product code DQA·2012-04-19
K113494 — NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TANobles Medical Technologies Ii, Inc.·Product code GAW·2012-04-19
K113789 — MODULAR PROXIMALLY FLUTED HIP STEMSmith & Nephew, Inc.·Product code MEH·2012-04-19
K113831 — PRIMUS HEARING INSTRUMENT TEST UNITAuditdata A/S·Product code ETW·2012-04-19
K120063 — VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEML&K BIOMED Co., Ltd.·Product code MAX·2012-04-19
K120076 — RESOLUTIONMD WEBCalgary Scientific, Inc.·Product code LLZ·2012-04-19
K120182 — NEOMED GASTROINTESTINAL TUBE AND ACCESSORIESNeomed, Inc.·Product code KNT·2012-04-19
K120196 — OLEA SPHEREOlea Medical·Product code LLZ·2012-04-19
K120201 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMGe Vingmed Ultrasound AS·Product code IYO·2012-04-19
K120234 — EZONO 3000Life-Tech, Inc.·Product code IYN·2012-04-19
K120255 — PHILIPS MICRODOSEPhilips Digital Mammography Sweden AB·Product code MUE·2012-04-19
K120316 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.·Product code JWH·2012-04-19
K120407 — 2MP MONOCHROME LCD MONITOR, RADIFORCE GX240Eizo Nanao Corporation·Product code LLZ·2012-04-19
K120699 — DC-T6 DIAGNOSTIC ULTRASOUND SYSTEMShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYN·2012-04-19
K120718 — INSTAPACS/INSTARISPACSMeddiff Technologies Pvt. , Ltd.·Product code LLZ·2012-04-19
K120722 — RIVAL PTA DILATATION CATHETERBard Peripheral Vascular, Inc.·Product code LIT·2012-04-19
K120818 — OTIS-C PLUSScience For Biomaterials·Product code HRS·2012-04-19
K120859 — PRE-LOADED GOLD VISICOIL CK MARKERRadiomed Corporation·Product code KXK·2012-04-19
K120863 — WHOLEY GUIDE WIRE SYSTEMCovidien, LLC·Product code DQX·2012-04-19
K120880 — ORBITNational Biomedical, LLC Dba Qrs Diagnostic·Product code BZG·2012-04-19
K120971 — ATLAS PTA BALLOON DILATATION CATHETERBard Peripheral Vascular, Inc.·Product code LIT·2012-04-19
K121010 — M7/M7T DIAGNOSTIC ULTRASOUND SYSTEMShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYN·2012-04-19
K121019 — OPTIMA NM/CT 640GE Healthcare·Product code KPS·2012-04-19
K102428 — WUNDER TESTHien Helen Nguyen·Product code LDJ·2012-04-18
K112440 — AB DENTAL DEVICES IMPLANTS AND ACCESSORIESA.B. Dental Devices , Ltd.·Product code DZE·2012-04-18
K112696 — TWIN PEAKS LUMBAR CAGEQualgenix, LLC·Product code MAX·2012-04-18
K112816 — ZHENJIANG ASURE MECHANICAL WHEELCHAIRZhenjiang Assure Medical Equipment Co., Ltd.·Product code IOR·2012-04-18
K113332 — ON CALL CHOSEN LANCING DEVICEACON Laboratories, Inc.·Product code FMK·2012-04-18
K113398 — NEXUS TKO-6, LUER-ACTIVATED DEVICENexus Medical, LLC·Product code FPA·2012-04-18
K113488 — JAZZY ELITE 6Pride Mobility Product Corporration·Product code ITI·2012-04-18
K113586 — SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENSSynergeyes, Inc.·Product code HQD·2012-04-18
K120531 — VERSAFITCUP CC TRIO-ADDITIONAL LINERSMedacta International·Product code LZO·2012-04-18
K120881 — MANTARAY GUIDEWIRESBridgepoint Medical·Product code DQX·2012-04-18
K103037 — IND URINARY TRACT INFECTION (UTI) TEST STRIPSInd Diagnostic, Inc.·Product code NGJ·2012-04-17
K110840 — LIACSordina S.P.A.·Product code IYE·2012-04-17
K111999 — HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINALHealgen Scientific,, LLC·Product code JIO·2012-04-17
K112305 — VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECESThunder Tiger Corp.·Product code EGS·2012-04-17
K112928 — RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAMERiverstone Resources Sdn Bhd·Product code LZA·2012-04-17
K113424 — LOFRIC SINGLE USE URINARY CATHETERAstra Tech AB·Product code EZD·2012-04-17
K113593 — NEXTGEN ALTIUS OCT SYSTEMBiomet Spine (Aka Ebi, LLC)·Product code KWP·2012-04-17
K120028 — AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSESPegavision Corporation·Product code LPL·2012-04-17
K120034 — RADIOGRAPHIC X-RAY SYSTEMOrich Medical Equipment (Tianjin Co., Ltd.·Product code KPR·2012-04-17
K120165 — INTRAOSSEOUS FIXATION SYSTEMOrthohelix Surgical Designs, Inc.·Product code HTY·2012-04-17
K120367 — 3MENSIO WORKSTATIONPie Medical Imaging BV·Product code LLZ·2012-04-17
K120591 — DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2Diamond Diagnostics, Inc.·Product code JIT·2012-04-17
K120816 — INZONE DETACHMENT SYSTEMStryker·Product code KRD·2012-04-17
K120850 — TARGET DETACHABLE COILStryker Neurovascular·Product code HCG·2012-04-17
K121001 — COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)Novitas Medical, LLC·Product code JOW·2012-04-17
K103767 — DUAL HEATED INFANT VREATHING CIROUITSFisher & Paykel Healthcare, Ltd.·Product code BZE·2012-04-16
K112290 — SUPERCATH Z3VTogo Medikit Co., Ltd.·Product code FOZ·2012-04-16
K113352 — TRANSCORP SPINAL ACCESS SYSTEMTranscorp, Inc.·Product code HRX·2012-04-16
K113802 — ESCALATE LAMINOPLASTY SYSTEMStryker Spine·Product code NQW·2012-04-16
K120117 — CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEMCodman & Shurtleff, Inc.·Product code KCT·2012-04-16
K120291 — OP SPINE SYSTEMOrthoPediatrics Corp.·Product code OSH·2012-04-16
K120403 — SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSERTransenterix, Inc.·Product code GCJ·2012-04-16
K120830 — NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)Carticept Medical, Inc.·Product code FRN·2012-04-16
K102327 — CLEARVISION DR 7000FJpi Healthcare Co, Ltd.·Product code MQB·2012-04-13
K110590 — INTRABEAM NEEDLE APPLICATORCarl Zeiss Surgical GmbH·Product code JAD·2012-04-13
K112141 — SMARTEPIL,DEPILASE YAG LASE PLUSCastle Laser Systems, Limited·Product code GEX·2012-04-13
K112717 — NUVASIVE NVJJB SYSTEMNuvasive, Inc.·Product code ETN·2012-04-13
K113096 — MICRO ICarefusion Germany 234 GmbH·Product code BZG·2012-04-13
K120032 — MECHANICAL WHEELCHAIRAikin Healthcare Co., Ltd.·Product code IOR·2012-04-13
K120062 — DRX-REVOLUTION MOBILE X-RAY SYSTEMCarestream Health, Inc.·Product code IZL·2012-04-13
K120092 — PLYMOUTH THORACOLUMBAR PLATE SYSTEMGlobus Medical, Inc.·Product code KWQ·2012-04-13

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