FDA 510(k) clearances — page 441

176,542 clearances on record, most recent first.

Clearances — page 441

44,001–44,100 of 176,542

K120814 — PADLOCK CLIP-12Aponos Medical Corp.·Product code PKL·2012-09-06
K121309 — ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICEAdvanced Surgical Concepts·Product code OTJ·2012-09-06
K121974 — CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMConformis, Inc.·Product code HSX·2012-09-06
K122005 — MAXLOCK EXTREME SYSTEMOrthohelix Surgical Designs, Inc.·Product code HRS·2012-09-06
K122397 — LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMDiaSorin, Inc.·Product code LFX·2012-09-06
K122442 — DEPUY CTA REVERSE SHOULDER SYSTEMDepuy France·Product code PHX·2012-09-06
K122628 — SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIESDatascope Corp., Cardiac Assist Division·Product code DSP·2012-09-06
K113376 — NEOSS PROACTIVE TAPERED IMPLANTNeoss, Ltd.·Product code DZE·2012-09-05
K113572 — LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDERCovidien, Formerly Valleylab, A Division of Tyco H·Product code GEI·2012-09-05
K120064 — TEST, BLOOD GLUCOSE SYSTEMHmd Biomedical, Inc.·Product code NBW·2012-09-05
K120792 — TIXOS IMPLANT SYSTEMLeader Italia S.R.L.·Product code DZE·2012-09-05
K120992 — METS SMILES TOTAL KNEE REPLACEMENTStanmore Implants Worldwide , Ltd.·Product code KRO·2012-09-05
K121383 — PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)Medical Components, Inc.·Product code FJS·2012-09-05
K121415 — MOLLRING MULTITASCLeMaitre Vascular, Inc.·Product code DWX·2012-09-05
K121654 — AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTIONI-Sens, Inc.·Product code CGA·2012-09-05
K121787 — BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTSBioHorizons Implant Systems, Inc.·Product code DZE·2012-09-05
K121893 — STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEMStryker Endoscopy·Product code GCJ·2012-09-05
K122030 — LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTONDegania Silicone , Ltd.·Product code KNT·2012-09-05
K122216 — RELIANCE ANTERIOR CERVICAL PLATE SYSTEMReliance Medical Systems, LLC·Product code KWQ·2012-09-05
K122379 — FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CMOstial Corporation·Product code LIT·2012-09-05
K122544 — TERUMO SURFLASH SAFETY I.V. CATHETERTerumo Corporation·Product code FOZ·2012-09-05
K122583 — UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEMSamsung Medison Co., Ltd.·Product code IYN·2012-09-05
K113321 — TENS BACK PAIN RELIEF SYSTEMSavia Limited·Product code NUH·2012-09-04
K113770 — ORTHOFIX GALAXY FIXATION SYSTEMOrthofix Srl·Product code KTT·2012-09-04
K120052 — CVINSIGHTIntelomed, Inc.·Product code DQA·2012-09-04
K121034 — IOI TOTAL HIPIconacy Orthopedic Implants, LLC·Product code LPH·2012-09-04
K122042 — CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBESMauna Kea Technologies·Product code OWN·2012-09-04
K122047 — ALAMO PAlliance Partners, LLC·Product code MAX·2012-09-04
K122155 — PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMVATECH Co., Ltd.·Product code MUH·2012-09-04
K122565 — ARC ENDOCUFFBoddingtons Plastics, Ltd.·Product code FED·2012-09-04
K113508 — DACRYOCATHArmadillo Biomedical, LLC·Product code OKS·2012-08-31
K113705 — PINTLER PATIENT WARMING SYSTEMPintler Medical·Product code DWJ·2012-08-31
K120819 — STALIF CCentinel Spine, Inc.·Product code OVE·2012-08-31
K121012 — FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.·Product code CEM·2012-08-31
K121196 — EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)Boston Scientific Corp·Product code LOX·2012-08-31
K121505 — DISPOSABLE HEMOSTASIS CHIPWilson-Cook Medical Inc./Cook Endoscopy·Product code PKL·2012-08-31
K121859 — TYSHAK NUCLEUSNuMED, Inc.·Product code DQY·2012-08-31
K122291 — THERMO SCIENTIFIC MAS OMNI-CARDIOMicrogenics Corporation·Product code JJY·2012-08-31
K113291 — SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300Simex Medizintechnik GmbH·Product code OMP·2012-08-30
K113472 — PRECISE SHP DIODE LASERCAO Group, Inc.·Product code GEX·2012-08-30
K113652 — LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF TAap Implantate AG·Product code HRS·2012-08-30
K113753 — ZIMMER DENTAL TAPERED SCREW-VENT XZimmer Dental, Inc.·Product code DZE·2012-08-30
K113830 — VANTERA CLINICAL ANALYZERLiposcience·Product code CDT·2012-08-30
K121040 — SMARTLYTE ELECTROLYTE ANALYZERDiamond Diagnostics, Inc.·Product code CEM·2012-08-30
K121311 — THIXO-GEL ULTRASOUND SPRAYCloverline International Pharma Services GmbH·Product code MUI·2012-08-30
K121678 — DTADGyrus Acmi, Inc.·Product code ERL·2012-08-30
K122066 — HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUSThe Binding Site Group , Ltd.·Product code JZG·2012-08-30
K122201 — PROTURA COUCH SOFTWAREMed-Tec, Inc. D/B/A Civco Medical Solutions·Product code JAI·2012-08-30
K122353 — CRAINFIX 2 TITANIUM CLAMP SYSTEMAesculap, Inc.·Product code GXN·2012-08-30
K122394 — RUBICON 18 SUPPORT CATHETERBoston Scientific Corp·Product code DQY·2012-08-30
K122444 — CERVICAL CAGEEisertech, LLC·Product code ODP·2012-08-30
K121230 — IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUEIvoclar Vivadent, AG·Product code EBF·2012-08-29
K121276 — NEURO VENTION LAMINPLASTY PLATING SYSTEMNeurovention, LLC·Product code NQW·2012-08-29
K121351 — SINUS DILATION SYSTEMEntrigue Surgical, Inc.·Product code LRC·2012-08-29
K121476 — INFILL GRAFT DELIVERY SYSTEMPinnacle Spine Group, LLC·Product code FMF·2012-08-29
K121760 — CAPSTONE SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code MAX·2012-08-29
K121889 — STAXX XD SYSTEMSpine Wave, Inc.·Product code MQP·2012-08-29
K121932 — HEM-7200-Z (BP742)Omron Healthcare, Inc.·Product code DXN·2012-08-29
K121934 — TOMOTHERAPY TREATMENT SYSTEMAccuray Incorporated·Product code IYE·2012-08-29
K122084 — INTRODUCER SET, MODEL ADELANTE-S SERIESOscor, Inc.·Product code DYB·2012-08-29
K122275 — ARTISAN EXTEND CONTROL CATHETERHansen Medical·Product code DRA·2012-08-29
K122276 — ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIPAtriCure, Inc.·Product code FZP·2012-08-29
K122281 — PADNET 2.0Biomedix, Inc.·Product code JOM·2012-08-29
K122316 — AZUR DETACHABLE 35MicroVention, Inc.·Product code KRD·2012-08-29
K122317 — TETRIS IISignus Medizintechnik GmbH·Product code MAX·2012-08-29
K122439 — INTELLIVUE PATIENT MONITORPhilips Medizin Systeme Boeblingen GmbH·Product code MHX·2012-08-29
K112255 — AIXPLORERSupersonic Imagine·Product code IYN·2012-08-28
K112967 — PMMA CAD/CAM DISCPolident D.O.O., Dental Products Industry·Product code EBG·2012-08-28
K113666 — XIA 3 SPINAL SYSTEMStryker Spine·Product code NKB·2012-08-28
K120246 — KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)Carestream Health, Inc.·Product code MUE·2012-08-28
K120629 — FDR GO FLEXFujifilm Medical System U.S.A., Inc.·Product code MQB·2012-08-28
K121091 — CATALYS PRECISION LASER SYSTEMOptimedica Corporation·Product code OOE·2012-08-28
K121251 — ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACKGalil Medical , Ltd.·Product code GEH·2012-08-28
K121257 — LARYNGEAL ELECTRODETechnomed Europe·Product code ETN·2012-08-28
K121400 — PAX-UNI3D, PHT-7500VATECH Co., Ltd.·Product code OAS·2012-08-28
K121482 — INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERYTheken Spine, LLC·Product code HRX·2012-08-28
K122027 — ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETERArrow International, Inc.·Product code CAZ·2012-08-28
K122249 — TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLETerumo (Philippines) Corporation·Product code FMI·2012-08-28
K122296 — SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATINGSmith & Nephew, Inc.·Product code LZO·2012-08-28
K122297 — ENLUXTRA HUMIFIBER WOUND DRESSINGBasf Venture Capital America, Inc.·Product code FRO·2012-08-28
K122323 — DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPISiemens Healthcare Diagnostics·Product code CJO·2012-08-28
K122359 — VITEK 2 STRPTOCOCCUS CEFTRIAXONEbioMerieux, Inc.·Product code LON·2012-08-28
K122528 — ULTHERA SYSTEMUlthera, Inc.·Product code OHV·2012-08-28
K120997 — BAROSTAT SOFTWARE OPTIONCrospon, Ltd.·Product code FFX·2012-08-27
K121264 — TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULEMedtronic Surgical Technologies·Product code HBE·2012-08-27
K121542 — PICIS WEIGHT BASED DOSE CONVERTERPicis, Inc.·Product code NDC·2012-08-27
K122302 — ACE MAGNESIUM REGENTAlfa Wassermann Diagnostics Technologies, LLC·Product code JGJ·2012-08-27
K110954 — ARJORAD STERILE WRAPArjo Wiggins Medical, Inc.·Product code FRG·2012-08-24
K113747 — RANDOX OPIATES ASSAYRandox Laboratories Limited·Product code DJG·2012-08-24
K120169 — INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENTGrifols USA, LLC·Product code CFF·2012-08-24
K120239 — ELEVANCEMidmark·Product code EIA·2012-08-24
K120906 — ZIMMER TRABECULAR METAL TOTAL ANKLEZimmer, Inc.·Product code HSN·2012-08-24
K121103 — LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT SLdr Spine USA, Inc.·Product code NKB·2012-08-24
K121329 — AIXPLORERSupersonic Imagine·Product code IYN·2012-08-24
K121619 — NUVASIVE POLYAXIAL SPINAL SCREWSNuvasive, Inc.·Product code NKB·2012-08-24
K121820 — INWAVEZynex Medical, Inc.·Product code KPI·2012-08-24
K121892 — PHANTOM PLUS CERAMIC CAGE SYSTEMAmedica Corp.·Product code MAX·2012-08-24
K121895 — ELECSYS HSV-2 IGG IMMUNOASSAYRoche Diagnostics·Product code JJX·2012-08-24
K122254 — INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIRSorin Group Italia S.R.L.·Product code DTZ·2012-08-24
K111603 — LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CMEp Dynamics, Inc.·Product code DYB·2012-08-23

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