FDA 510(k) clearances — page 472

176,542 clearances on record, most recent first.

Clearances — page 472

47,101–47,200 of 176,542

K102359 — PICASSO/ PICASSO LITE/ PICASSO PERIOAmd Lasers, LLC·Product code GEX·2011-09-16
K102778 — CELLAVISION DM1200 WITH THE BODY FLUID APPLICTIONCellaVision AB·Product code JOY·2011-09-16
K111278 — Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICEOtto Bock Healthcare LP·Product code ITI·2011-09-16
K111355 — ECHOBRIGHTLife-Tech, Inc.·Product code CAZ·2011-09-16
K111490 — MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHSEv3, Inc.·Product code KRA·2011-09-16
K111559 — SURGICAL MASKSShanghai Neo-Medical Import & Export Co., Ltd.·Product code FXX·2011-09-16
K111629 — TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001Encore Medical L.P.·Product code PHX·2011-09-16
K111711 — JOURNEY II BCS KNEE SYSTEMSmith & Nephew, Inc.·Product code JWH·2011-09-16
K111720 — AVIAFITFlowmedic , Ltd.·Product code JOW·2011-09-16
K111728 — EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEMEps Bio Technology Corp.·Product code CGA·2011-09-16
K111782 — BEAUTISEALANTShofu Dental Corporation·Product code EBC·2011-09-16
K111836 — PERMASHADE VENEER CEMENTUltradent Products, Inc.·Product code EMA·2011-09-16
K112067 — NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)Carticept Medical, Inc.·Product code FRN·2011-09-16
K112451 — S8 DIAGNOSTIC ULTRASOUND SYSTEMSonoscape Company Limited·Product code IYN·2011-09-16
K112596 — ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI·Product code IYN·2011-09-16
K101898 — R4 ACERT ULTRASOUND REPORTING SYSTEMR4, LLC·Product code LLZ·2011-09-15
K102816 — GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPSApex BioTechnology Corp.·Product code NBW·2011-09-15
K103089 — SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTSMis - Implant Technologies , Ltd.·Product code DZE·2011-09-15
K103515 — EQUAL DOSENucletron Corporation·Product code MUJ·2011-09-15
K103639 — VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRICVortran Medical Technology 1, Inc.·Product code CAP·2011-09-15
K110033 — FEEL-DRCSImfou Co., Ltd.·Product code LLZ·2011-09-15
K110370 — Q-CLEARLight Age, Inc.·Product code PDZ·2011-09-15
K110766 — KOLPLUX SYSTEMKolplast CI Ltda·Product code HIB·2011-09-15
K111003 — BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVELBiodenta Swiss AG·Product code DZE·2011-09-15
K111457 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek·Product code NKB·2011-09-15
K111510 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek, Inc.·Product code NKB·2011-09-15
K111694 — ASTRACandelis, Inc.·Product code LLZ·2011-09-15
K111731 — MOLECULAR BREAST IMAGING SOFTWAREGamma Medica-Ideas Incorporated·Product code LLZ·2011-09-15
K111763 — PATHASSIST LIGHT FIBEREntellus Medical, Inc.·Product code LRC·2011-09-15
K111767 — NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KITNess-Neuromuscular Electrical Stimulation Systems·Product code GZI·2011-09-15
K111966 — PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XCCooperVision, Inc.·Product code LPL·2011-09-15
K112025 — SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEMSpinal USA·Product code KWP·2011-09-15
K112075 — VITEK 2 STRPTOCOCCUS AMPICILLINbioMerieux, Inc.·Product code LON·2011-09-15
K112176 — SILICONE SPHERESOculo Plastik, Inc.·Product code HPZ·2011-09-15
K112360 — QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIESMaquet Cardiopulmonary, AG·Product code DTZ·2011-09-15
K112366 — 4CH FLEX SPEEDERToshiba Medical Systems Coporation, Japan·Product code MOS·2011-09-15
K112372 — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMPCardiac Assist, Maquet Cardiovascular, LLC·Product code DSP·2011-09-15
K112385 — TRAGET DETACHABLE COILStryker Neurovascular·Product code HCG·2011-09-15
K103426 — LITE PELVIC FLOOR REPAIR KITSBoston Scientific Corp·Product code OTP·2011-09-14
K103648 — COLLAGEN POWDERInnocoll Pharmaceuticals, Ltd.·Product code KGN·2011-09-14
K103810 — KJ SUBMERGED SYSTEMKj Meditech Co., Ltd.·Product code DZE·2011-09-14
K110309 — FOB ONE STEP RAPID TESTOrient Gene Biotech·Product code KHE·2011-09-14
K111322 — CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARDChemtron Biotech, Inc.·Product code JXM·2011-09-14
K111360 — SHEAUMANN PL-980Sheaumann Lasers·Product code GEX·2011-09-14
K111612 — DIGITAL RETINAL CAMERACanon, Inc.·Product code HKI·2011-09-14
K111743 — THE INSYNC CERAMIC SYSTEMJensen Industries, Inc.·Product code EIH·2011-09-14
K111814 — PADLOCKReliance Orthodontic Products, Inc.·Product code DYH·2011-09-14
K111996 — ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2Elitechgroup·Product code JJY·2011-09-14
K112113 — ELECSYS MYOGLOBIN CALCHECK 5Roche Diagnostics·Product code JJX·2011-09-14
K112196 — OCTOTMPORTDalim Surgnet Corporation·Product code OTJ·2011-09-14
K112198 — EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLEBoston Scientific Corporation·Product code ODG·2011-09-14
K112465 — VITAL SIGNS MONITORAdvanced Instruments, Inc.·Product code DQA·2011-09-14
K101769 — EPISILCamurus AB·Product code OLR·2011-09-13
K102483 — SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104Sunset Healthcare Solutions, LLC·Product code CAH·2011-09-13
K103461 — COLGATE DESENSITIZING DENTAL CREAMColgate-Palmolive Co.·Product code LBH·2011-09-13
K110659 — MEDICAL CONCEPTS INTERBODY FUSION SYSTEMMedical Concepts, Inc.·Product code MAX·2011-09-13
K110891 — THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETERLeMaitre Vascular, Inc.·Product code DQY·2011-09-13
K110945 — POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVESZhaoyang Plastic Co., Ltd.·Product code LYZ·2011-09-13
K111115 — CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEMCaptiva Spine, Inc.·Product code MNI·2011-09-13
K111270 — REUSABLE STIMULATING ELECTRODESBio Protech, Inc.·Product code GXY·2011-09-13
K111359 — SHEAUMANN PL-1064Sheaumann Lasers·Product code GEX·2011-09-13
K111660 — XELIS CARDIACInfinitt Co., Ltd.·Product code LLZ·2011-09-13
K111775 — JBAIDS INFLUENZA A&B DETECTION KITU.S. Army Medical Material Development Acitvity·Product code OCC·2011-09-13
K111778 — JBAIDS INFLUENZA A SUBTYPING KITU.S Army Medical Materiel Development Activity·Product code OQW·2011-09-13
K112031 — ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATIONAlma Lasers, Inc.·Product code GEX·2011-09-13
K112047 — AMCOM COMMTECH MESSENGERAmcom Software,Inc.·Product code MSX·2011-09-13
K110713 — WATERPAP VALVEAirways Development, LLC·Product code BYE·2011-09-12
K111177 — JUELL HARD CUREJuell Dental·Product code EBI·2011-09-12
K111178 — JUELL SOFT CUREJuell Dental·Product code EBI·2011-09-12
K111390 — SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..Cendres & Metaux SA·Product code NHA·2011-09-12
K111438 — REKA E100Reka Pte, Ltd.·Product code DPS·2011-09-12
K111484 — DISCOVERYIntuitive Spine, LLC·Product code ODP·2011-09-12
K111724 — STRAUMANN TIBRUSHStraumann USA·Product code ELB·2011-09-12
K112400 — SMARTSHEARSNuscience Consulting and Management Group, LLC·Product code FZT·2011-09-12
K101986 — ASAHI ULTIMATEBROS 3 PTCA GUIDE WIREAsahi Intecc Co., Ltd.·Product code DQX·2011-09-09
K102633 — BIOTEQ ANGIOGRAPHIC CATHETERBioteque Corp.·Product code DQO·2011-09-09
K103489 — GE VEO RECONSTRUCTION OPTIONGeneral Electric Co.·Product code JAK·2011-09-09
K110086 — IFS PROFILE PLATES, SCREWS, AND WASHERSInternal Fixation Systems, Inc.·Product code HRS·2011-09-09
K110754 — CRYOPEN CRYOSURGICAL SYSTEM, K102214Cryopen, Inc.·Product code GEH·2011-09-09
K111060 — MRGFUS PELVIC PA COIL MODEL 1.0Insightech, Ltd.·Product code MOS·2011-09-09
K111116 — ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000Datex-Ohmeda·Product code CBK·2011-09-09
K111285 — AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTINGSalient Surgical Technologies, Inc.·Product code GEI·2011-09-09
K111346 — RESOLUTIONMD MOBILE MODEL RMB-MOB-2XCalgary Scientific, Inc.·Product code LLZ·2011-09-09
K111622 — UNIMAX ANTI-FOG SOLUTIONUnimax Medical Systems, Inc.·Product code OCT·2011-09-09
K111626 — ENDOSKELETON(R) TASTitan Spine, LLC·Product code OVD·2011-09-09
K111635 — SMITH & NEPHEW RJ CONSTRAINED LINERSSmith & Nephew, Inc.·Product code KWZ·2011-09-09
K111704 — AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOXAvinger, Inc.·Product code DQY·2011-09-09
K111759 — .DECIMAL ELECTRON APERTURE.Decimal, Inc.·Product code IXI·2011-09-09
K111887 — CLOSUREFAST RADIOFREQUENCY CATHETERCovidien·Product code GEI·2011-09-09
K112313 — TOSHIBA 3T EXTRA LARGE KNEE COILQuality Electrodynamics·Product code MOS·2011-09-09
K112327 — SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIESCardiac Assist, Maquet Cardiovascular, LLC·Product code DSP·2011-09-09
K112395 — WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TESTGuangzhou Wondfo Biotech Co., Ltd.·Product code LFG·2011-09-09
K103132 — FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZIOculus Private Limited·Product code LPL·2011-09-08
K103615 — ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARDAlfa Wassermann Diagnostic Technologies, Inc.·Product code CDN·2011-09-08
K110403 — PROLINK ADHESIVES (PROLINK, PROLINK SE)Silmet , Ltd.·Product code KLE·2011-09-08
K110818 — POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTSPolymedco, Inc.·Product code CIX·2011-09-08
K111166 — A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)Spineworks, LLC·Product code MAX·2011-09-08
K111462 — FIXATE TISSUE BANDAnulex Technologies, Inc.·Product code GZB·2011-09-08
K111505 — RTVUE CAM WITH CORNEAL POWER UPGRADEOptovue, Inc.·Product code OBO·2011-09-08
K111577 — MEDLINE VIAL DECANTERMedline Industries, Inc.·Product code LHI·2011-09-08

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