FDA 510(k) clearances — page 415

176,542 clearances on record, most recent first.

Clearances — page 415

41,401–41,500 of 176,542

K130083 — DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTUREDemetech Corp.·Product code GAM·2013-07-17
K130766 — ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDECook, Inc.·Product code DQX·2013-07-17
K130906 — ENDOFLIP CATHETERCrospon, Ltd.·Product code FFX·2013-07-17
K130987 — VALUTRODE NEUROSTIMLATION ELECTRODESAxelgaard Mfg. Co., Ltd.·Product code GXY·2013-07-17
K131077 — LIFE SPINE PLATEAU SPACER SYSTEMLife Spine·Product code MAX·2013-07-17
K131544 — COBAS C BILIRUBIN TOTAL GEN.3Roche Diagnostics·Product code CIG·2013-07-17
K131853 — MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZERMentor Worldwide, LLC·Product code MRD·2013-07-17
K122402 — LPP (LOW PROFILE PORT)Pfm Medical, Inc.·Product code LJT·2013-07-16
K130536 — EXPORT ADVANCE ASPIRATION CATHETERMedtronic, Inc.·Product code QEZ·2013-07-16
K131120 — AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEMSTERIS Corporation·Product code MLR·2013-07-16
K131233 — HERMES MEDICAL IMAGING SUITE V5.3Hermes Medical Solutions AB·Product code KPS·2013-07-16
K131358 — BD PEN NEEDLEBecton, Dickinson & CO·Product code FMI·2013-07-16
K131428 — RADVISIONAcoustic Medsystems, Inc.·Product code MUJ·2013-07-16
K131434 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEMVisionsense, Ltd.·Product code GWG·2013-07-16
K131504 — UNIVERSAL OPAQUEShofu Dental Corporation·Product code EBF·2013-07-16
DEN110019 — NEBA SYSTEMLexicor Medical Technology, LLC·Product code NCG·2013-07-15
K123364 — 25OH VITAMIN D TOTAL ELISA TESTDiasource Immunoassays, S.A.·Product code MRG·2013-07-15
K130051 — 611 ANKLE FUSION NAILTornier S.A.S.·Product code HSB·2013-07-15
K130186 — DENTEK EASY BRUSH WITH FLUORIDEDen Tek Oral Care, Inc.·Product code EFW·2013-07-15
K130253 — TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATIONBeckman Coulter, Inc.·Product code PER·2013-07-15
K130360 — CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSIONConstant Care, LLC·Product code DRG·2013-07-15
K130585 — PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMVATECH Co., Ltd.·Product code MUH·2013-07-15
K130657 — LINKDR 2.0 DIABETES MANAGEMENT SOFTWAREAll Medicus Co., Ltd.·Product code NBW·2013-07-15
K130953 — NEOTIS; NEOTIS 50Sbm Sciences For Bio Materials·Product code MQV·2013-07-15
K131040 — EXTAVIPRO STERICAN 30GB.Braun Melsungen AG·Product code FMI·2013-07-15
K131185 — ANA SCREEN ELISA (IGG)Euroimmun US·Product code LJM·2013-07-15
K131382 — EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTALInvivo Corporation·Product code MWI·2013-07-15
K131763 — TRUSCOPE SERIES PATIENT MONITORGuangdong Biolight Meditech Co., Ltd.·Product code MHX·2013-07-15
DEN110004 — CABOCHON SYSTEMCabochon Aesthetics, Inc.·Product code OUP·2013-07-12
DEN110006 — VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATORSTERIS Corporation·Product code OWP·2013-07-12
K123366 — SURGITRON 4.0 DUAL RF S5-IECEllman International, Inc.·Product code GEI·2013-07-12
K123599 — INGENUITY DIGITAL PET/CTPhilips Healthcare (Cleveland)·Product code KPS·2013-07-12
K130315 — IPULSE HAIR REMOVAL SYSTEMCyden Limited·Product code OHT·2013-07-12
K130420 — SOLEAConvergent Dental, Inc.·Product code GEX·2013-07-12
K130806 — NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODENeurovision Medical Products, Inc.·Product code PDQ·2013-07-12
K131036 — YAMAHACHI DENTURE BASE RESINSYamahachi Dental Manufacturing Co.·Product code EBI·2013-07-12
K131087 — SHARPSTANK REUSABLE SHARPS CONTAINERRehrig Pacific Company·Product code MMK·2013-07-12
K131227 — PADSCAN HD SERIES BLADDER SCANNERCarenoso Technology Co., Ltd.·Product code IYO·2013-07-12
K131417 — FACET FIXXNexxt Spine, LLC·Product code MRW·2013-07-12
K131424 — MIPLATFORM MEDICAL IMAGING SUITEHinacom Software and Technology, Ltd.·Product code LLZ·2013-07-12
K131514 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMGe Vingmed Ultrasound AS·Product code IYN·2013-07-12
K131547 — LANX FUSION SYSTEMLanx, Inc.·Product code OVD·2013-07-12
K131637 — ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)Rotation Medical, Inc.·Product code GDW·2013-07-12
K131804 — REMEL XPECT FLU A&BRemel, Inc.·Product code GNX·2013-07-12
K121310 — MESOTHELIUM DENTAL MEMBRANEKensey Nash Corporation·Product code NPL·2013-07-11
K123075 — BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413EWell-Life Healthcare Limited·Product code NGX·2013-07-11
K123343 — THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSMicrogenics Corp.·Product code MLM·2013-07-11
K123881 — HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.·Product code MKJ·2013-07-11
K130225 — QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICESilverbay, LLC, D/B/A Quasar Bio-Tech·Product code OHS·2013-07-11
K130339 — CLINICAL ALERT NOTIFICATIONExtension , Inc.·Product code MSX·2013-07-11
K130424 — STIMEL-03Stimel, Ltd.·Product code IPF·2013-07-11
K130460 — NXSTAGE DOSING CALCULATORNxstage Medical, Inc.·Product code FKP·2013-07-11
K131248 — ETCH GELDmg America, LLC·Product code KLE·2013-07-11
K131278 — MONTERIS MEDICAL NEUROBLATE SYSTEMMonteris Medical, Inc.·Product code GEX·2013-07-11
K131282 — NEXUS HEMORRHOID LIGATORInx Medical·Product code FHN·2013-07-11
K131520 — NEXUS ANTERIOR CERVICAL PLATE SYSTEMCore-Nexus·Product code KWQ·2013-07-11
K124045 — FUSEFORCE IMPLANT SYSTEMSolana Surgical, LLC·Product code JDR·2013-07-10
K124062 — QDC-PRO, AND NOX-RIPNox Medical·Product code MNR·2013-07-10
K130391 — EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILATBoston Scientific Corp·Product code LOX·2013-07-10
K131007 — AIGIS RX N MEDIUM; AIGIS RX N LARGETyrx, Inc.·Product code FTL·2013-07-10
K131269 — DLP CORONARY OSTIAL PERFUSION CANNULAEMedtronic, Inc.·Product code DWF·2013-07-10
K131331 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)Becton, Dickinson & CO·Product code LON·2013-07-10
K131338 — DERMA HOODGlobalmedia Group, LLC·Product code PEQ·2013-07-10
K131496 — BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)Bsn Medical, Inc.·Product code DWL·2013-07-10
K131738 — IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL HPhadia AB·Product code DHB·2013-07-10
K130324 — STATSEAL DISCBiolife, LLC·Product code QSY·2013-07-09
K130879 — NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUSNexus Medical, LLC·Product code FPA·2013-07-09
K131072 — ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILICColoplast A/S·Product code OCY·2013-07-09
K130676 — AMBIO REMOTE HEALTH MONITORING SYSTEMArrayent Health, LLC D/B/A Ambio Health·Product code DRG·2013-07-08
K131463 — WRIST AUTOMATIC BLOOD PRESSURE MONITORHonsun (Nantong) Co., Ltd.·Product code DXN·2013-07-08
K130183 — SFI BAR ABUTMENTSSterngold Dental, LLC·Product code NHA·2013-07-07
K121178 — TRANSCORP ACIF SYSTEMTranscorp, Inc.·Product code ODP·2013-07-05
K122424 — ISUS IMPLANT SUPRASTRUCTURESDentsply International, Inc.·Product code NHA·2013-07-05
K123234 — ERMIS STERILIZATION CONTAINER SYSTEMErmis Medizintechnik·Product code KCT·2013-07-05
K123471 — ETII SA FIXTURE SYSTEMHiossen, Inc.·Product code DZE·2013-07-05
K130211 — AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETSSpsmedical Supply Corp.·Product code JOJ·2013-07-05
K130404 — TIBURON SURGICAL DRAPECardinal Health200, LLC·Product code KKX·2013-07-05
K130473 — NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)Hartalega Sdn Bhd·Product code LZA·2013-07-05
K131078 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEMSTERIS Corporation·Product code MED·2013-07-05
K131123 — CLICKFINE AUTOPROTECT PEN NEEDLEYpsomed AG·Product code FMI·2013-07-05
K131125 — CLICKFINE PEN NEEDLEYpsomed AG·Product code FMI·2013-07-05
K131283 — PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDESWrightmedicaltechnologyinc·Product code HSN·2013-07-05
K131511 — DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORRChangzhou Sinolinks Medical Innovation Co., Ltd.·Product code GDW·2013-07-05
K131599 — QUICK VUE INFLUENZAQuidel Corporation·Product code GNX·2013-07-05
K131606 — SOFIA INFLUENZA A+B FIAQuidel Corp.·Product code GNX·2013-07-05
K131666 — ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATINGMaquet Cardiopulmonary, AG·Product code DWF·2013-07-05
K131671 — MECTALIFMedacta International·Product code MAX·2013-07-05
K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MICInternational Technidyne Corp.·Product code GGN·2013-07-03
K123074 — IMEC, IPM AND BENEVIEW T1 PATIENT MONITORSShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code MHX·2013-07-03
K123171 — ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONTHORIBA ABX SAS·Product code CJY·2013-07-03
K123177 — STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEMLaserstim, Inc.·Product code ILY·2013-07-03
K123256 — HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUSThe Binding Site Group , Ltd.·Product code DEM·2013-07-03
K123641 — CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISHHertart·Product code MQK·2013-07-03
K123983 — FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERSQualigen, Inc.·Product code MRG·2013-07-03
K124035 — 2008K@HOME HEMODIALYSIS MACHINEFresenius Medical Care North America·Product code ONW·2013-07-03
K130376 — DYNASTY ACETABULAR SYSTEM WITH CERAMICWrightmedicaltechnologyinc·Product code LZO·2013-07-03
K130442 — NEWTOM VGI AND NEWTOM 5GQr S.R.L.·Product code OAS·2013-07-03
K130553 — ABSOCLEARPharmaplast S.A.E.·Product code FRO·2013-07-03
K130656 — IFUSIONOptovue, Inc.·Product code HKI·2013-07-03
K130805 — MENICON UNIQUE PH MULTI-PURPOSE SOLUTIONMenicon Co, Ltd.·Product code MRC·2013-07-03

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