FDA 510(k) clearances — page 945

176,637 clearances on record, most recent first.

Clearances — page 945

94,401–94,500 of 176,637

K971497 — OSTEONICS ANTEVERTED NECK HIP STEMOsteonics Corp.·Product code LZO·1997-07-16
K971652 — P.F.C. SIGMA INSET PATELLAJohnson & Johnson Professionals, Inc.·Product code JWH·1997-07-16
K971741 — DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLEHowmedica Corp.·Product code JDQ·1997-07-16
K972027 — ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)Zhermack S.P.A.·Product code ELW·1997-07-16
K964325 — VISUALEYES: VIDEO EYE MONITORMicromedical Technologies, Inc.·Product code GWN·1997-07-15
K964646 — VIDEO EYE TRAKKERMicromedical Technologies, Inc.·Product code GWN·1997-07-15
K965068 — MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWAREToshiba America Medical Systems, In.C·Product code LNH·1997-07-15
K970160 — UNIJECT SURGICAL GLOVESUniject Gloves , Ltd.·Product code KGO·1997-07-15
K970414 — CONFOCAL MICROSCOPECon-S , Ltd.·Product code HJO·1997-07-15
K970683 — ZENTIH FLOWABLE COMPOSITE (MULTIPLE)Foremost Dental Mfg., Inc.·Product code EBF·1997-07-15
K971002 — SMILE WITH CONFIDENCELloyd V. Ziemendorf·Product code EHS·1997-07-15
K971168 — ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATEBaxter Healthcare Corp·Product code MEB·1997-07-15
K971355 — NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIESNihon Kohden America, Inc.·Product code LDD·1997-07-15
K971647 — LL BI-FOCAL, DAILY WEAR CONTACT LENSLombart Lenses, Ltd.·Product code LPL·1997-07-15
K972096 — BIVALVE NASAL SPLINTBoston Medical Products, Inc.·Product code LYA·1997-07-15
K951459 — ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEOrtho Diagnostic Systems, Inc.·Product code GKZ·1997-07-14
K960974 — COBE CENTURY PERFUSION PUMPCobe Cardiovascular, Inc.·Product code DWB·1997-07-14
K962539 — GANTEX MODEL NSG-75PFAmerican Pro Latex, Inc.·Product code KGO·1997-07-14
K963208 — NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)Neurotron Medical·Product code JXE·1997-07-14
K963565 — MRI NEEDLESCook, Inc.·Product code FCG·1997-07-14
K963789 — DTX-100 BONE DENSITOMETEROsteometer Meditech A/S·Product code KGI·1997-07-14
K964297 — N-ASSAY TIA C4 TEST KITCrestat Diagnostics, Inc.·Product code DBI·1997-07-14
K964298 — N-ASSAY TIA MULTI V-NLCrestat Diagnostics, Inc.·Product code CZW·1997-07-14
K964299 — N-ASSAY TIA MULTI V-NLCrestat Diagnostics, Inc.·Product code LKL·1997-07-14
K964300 — N-ASSAY TIA MULTI V-NLCrestat Diagnostics, Inc.·Product code DBI·1997-07-14
K964301 — N-ASSAY TIA MULTI V-NLCrestat Diagnostics, Inc.·Product code DAD·1997-07-14
K965024 — N-ASSAY TIA C1-INACTIVATOR TEST KITCrestat Diagnostics, Inc.·Product code DBA·1997-07-14
K965100 — N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KITCrestat Diagnostics, Inc.·Product code DEM·1997-07-14
K965128 — CYNOSURE PHOTOGENICA VLV CUTANEOUS VASCULAR LESION LASERCynosure, Inc.·Product code GEX·1997-07-14
K965130 — CHROMOPHAREBerchtold Holding GmbH·Product code FSY·1997-07-14
K970546 — ACS DIGITOXINChiron Diagnostics Corp.·Product code LFM·1997-07-14
K970763 — MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITORMedical Data Electronics·Product code DQA·1997-07-14
K970770 — LATEX EXAMINATION GLOVESOon Corp. Resources·Product code LYY·1997-07-14
K970819 — TARGOBEAMFerguson Medical·Product code JAK·1997-07-14
K971306 — FG INFUSION CATHETERCordis Neurovascular, Inc.·Product code KRA·1997-07-14
K971385 — SUNGLASSESKosway Industries Co., Ltd.·Product code HQY·1997-07-14
K971393 — MYCOPLASMA IGG ELISA TEST SYSTEMImmunoprobe, Inc.·Product code LJZ·1997-07-14
K971395 — GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCETarget Therapeutics·Product code DQX·1997-07-14
K971474 — MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOLMedtronic Vascular·Product code DTE·1997-07-14
K971538 — MENTOR GEMINI HEMOSTATIC ERASERMentor Ophthalmics, Inc.·Product code HQO·1997-07-14
K971561 — PROVEST-PROTECTIVE RESTRAINTJemm Medical Products·Product code FMQ·1997-07-14
K971566 — CREATINE KINASE-MB REAGENT SETHorizon Diagnostics, Inc.·Product code CGS·1997-07-14
K971572 — VISTA BRITE TIP CATHETERSCordis Corp.·Product code DQY·1997-07-14
K971618 — ALCON CONTACT LENS CASEAlcon Laboratories·Product code LRX·1997-07-14
K971646 — 4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETERCordis Corp.·Product code DQO·1997-07-14
K971675 — SNT STEREOTACTIC LOCALIZATION SYSTEMSurgical Navigation Technologies, Inc.·Product code HAW·1997-07-14
K971697 — ETEST FOR LEVOFLOXACINAb Biodisk·Product code JWY·1997-07-14
K971776 — ECHOVACSVmi Technologies·Product code LLZ·1997-07-14
K971795 — AUTOMATED CHAMBER MAINTENANCE MODULEParadigm Medical Industries, Inc.·Product code HQC·1997-07-14
K971926 — QUIKSTRIP ONE STEP COCAINE TESTDrial Consultants, Inc.·Product code DIO·1997-07-14
K971945 — PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVETillotson Healthcare Corp.·Product code KGO·1997-07-14
K972190 — THYROGLOBULIN ASSAY SYSTEMAmerican Laboratory Products Co., Ltd.·Product code JZO·1997-07-14
K972286 — FACTOR DEFICIENT PLASMAS - FACTOR XI (11)Universal Reagents, Inc.·Product code GJT·1997-07-14
K972288 — FACTOR DEFICIENT PLASMAS - FACTOR IX (9)Universal Reagents, Inc.·Product code GGP·1997-07-14
K972330 — INNOFLUOR PHENOBARBITAL ASSAY SYSTEMOxis Intl., Inc.·Product code LGQ·1997-07-14
K972362 — FOVS, BRILLARTE, ETC...Sunglass City, Inc.·Product code HQY·1997-07-14
K970461 — CELL ROBOTICS ER: YAG SURGICAL LASERCell Robotics, Inc.·Product code GEX·1997-07-11
K971105 — MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEMAvecor Cardiovascular, Inc.·Product code DTN·1997-07-11
K971988 — ALLEN, ULTRA AND SMART SOCKETSAllen Medical Systems, Inc.·Product code FQO·1997-07-11
K964190 — ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZERBiotronik, Inc.·Product code DTE·1997-07-10
K965079 — SOMNITOR 32K SLEEP ACTIVITY MONITORNeurim Pharmaceuticals, Ltd.·Product code LEL·1997-07-10
K970051 — MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICESmith and Nephew Donjoy, Inc.·Product code HCC·1997-07-10
K970371 — FLOTEC OXYSAVRR (S)Flotec, Inc.·Product code NFB·1997-07-10
K970988 — FAR-EAST BOUFFANT CAPSFar East Science & Technology Development Co., Ltd.·Product code LYU·1997-07-10
K971191 — FAR-EAST SHOE COVERSFar East Science & Technology Development Co., Ltd.·Product code FXP·1997-07-10
K971546 — SOMA 900 TRANSPORT BEDNova Technologies, Inc.·Product code FNL·1997-07-10
K971722 — TRANS VAGINAL NEEDLE GUIDEProtek Medical Products, Inc.·Product code ITX·1997-07-10
K972006 — ACTA OEM MODULEInteractive Consulting, Inc.·Product code EBZ·1997-07-10
K972078 — POST-STOP EPISTAXIS CATHETERBoston Medical Products, Inc.·Product code EMX·1997-07-10
K972259 — PRO CHECK DIGITAL PACIFIER THERMOMETERMicro Weiss Electronics·Product code FLL·1997-07-10
K964920 — RPI DUAL PORT IRRIGATION ADAPTERRidge Products, Inc.·Product code KNT·1997-07-09
K970011 — ESCORT II CLINICAL THERMOMETRY MODULE (CTM)Medical Data Electronics·Product code FLL·1997-07-09
K970236 — THERAPLAN PLUS VERSION 1.2Theratronics, Inc.·Product code IYE·1997-07-09
K971068 — 34MM SCARF THREAD-HEAD(TM) SCREWLandos, Inc.·Product code HWC·1997-07-09
K971069 — TWIST-OFF (TM) SCREWLandos, Inc.·Product code HWC·1997-07-09
K971070 — SCARF THREAD-HEAD (TM) HEAD SCREWLandos, Inc.·Product code HWC·1997-07-09
K971079 — INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWAREInterlogics, Inc.·Product code KQX·1997-07-09
K971194 — NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIESNihon Kohden America, Inc.·Product code LDD·1997-07-09
K971321 — OSTEO COMPRESSION CONDYLE SCREW SYSTEMOsteonics Corp.·Product code HRS·1997-07-09
K971332 — AMS MAINSTAY UROLOGIC BONE ANCHORAmerican Medical Systems, Inc.·Product code MBI·1997-07-09
K971337 — EPITECH ISLAND DRESSINGSRynel, Ltd. Inc.·Product code KMF·1997-07-09
K971358 — BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MMArthrex, Inc.·Product code MAI·1997-07-09
K971381 — POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVESAllegiance Healthcare Corp.·Product code KGO·1997-07-09
K971404 — SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASERSchwartz Electro-Optics, Inc.·Product code GEX·1997-07-09
K971409 — OSTEONICS ALUMINA C-TAPER HEADOsteonics Corp.·Product code LZO·1997-07-09
K971426 — HEADLOC CERAMIC HEADOrtho Development Corp.·Product code LZO·1997-07-09
K971429 — INTERSEAL ACETABULAR SCREW HOLE PLUGWrightmedicaltechnologyinc·Product code LPH·1997-07-09
K971435 — HEADLOC CERAMIC FEMORAL HEADSOrtho Development Corp.·Product code LZO·1997-07-09
K971654 — OSTEO COMPRESSION HIP SCREW SYSTEMOsteonics Corp.·Product code HWC·1997-07-09
K971700 — BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCERBiosound, Inc.·Product code ITX·1997-07-09
K971815 — ASC BALANCE MIDDLEWEIGHT GUIDE WIREGuidant Corp.·Product code DQX·1997-07-09
K972026 — SP4044 & SP4055 LUX MODULESSatelec·Product code ELC·1997-07-09
K972269 — DISPOSABLE PATIENT RETURN ELECTRODEErbe USA, Inc.·Product code GEI·1997-07-09
K961732 — KARLandos, Inc.·Product code MEH·1997-07-08
K970739 — RMI HEMOCONCENTRATOR PREFERENCE PACKResearch Medical, Inc.·Product code KDI·1997-07-08
K971342 — DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)Disk Whisk, Inc.·Product code HWE·1997-07-08
K971550 — KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGSHowmedica Corp.·Product code JWH·1997-07-08
K971702 — FAR-EAST BARRIER GOWNSFar East Science & Technology Development Co., Ltd.·Product code FYC·1997-07-08
K972000 — X-RAY ASSIST BARRalph Lindel, D.C.·Product code KPR·1997-07-08
K972001 — NICAS(TM) ELECTRODENi Medical·Product code DRX·1997-07-08

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