FDA 510(k) clearances — page 1430

176,637 clearances on record, most recent first.

Clearances — page 1430

142,901–143,000 of 176,637

K864052 — TUBULITEC PRIMERDental Dimensions Supply Co.·Product code LBH·1986-12-05
K864053 — TUBULITEC LINERDental Dimensions Supply Co.·Product code EJK·1986-12-05
K864098 — TELECTRONICS SREW-IN/SLIM LINE PACING LEADSDaig Corp.·Product code DTB·1986-12-05
K864147 — AQUAVALVERespiratory Care, Inc.·Product code BYH·1986-12-05
K864394 — EMERSON 3MV VOLUME VENTILATORJ. H. Emerson Co.·1986-12-05
K864428 — MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTERIntermedics, Inc.·Product code DTB·1986-12-05
K864564 — MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEADIntermedics, Inc.·Product code DTB·1986-12-05
K864585 — ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCHAdvanced Cardiovascular Systems, Inc.·Product code DQX·1986-12-05
K850449 — DIGITAL PULSE METER HRM-100E & ETC.Sanyo Electric, Inc.·Product code DRT·1986-12-04
K853733 — MED-PEN/MED-POINTGarid, Inc.·Product code CGA·1986-12-04
K861725 — INTRACATH INTRAVENOUS CATHETER PLACEMENT UNITParke-Davis Co.·Product code FOZ·1986-12-04
K861985 — 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)3M Company·Product code MVR·1986-12-04
K862806 — URINE DIAGNOSTIC REAGENT STRIPSAmatech International, Inc.·Product code JJB·1986-12-04
K863066 — TRANSFERMETERJ. D. Assoc.·Product code JQF·1986-12-04
K863086 — SAPPHIRE LASER BLADES (LASER BLADES) ND: YAGCooper Lasersonics, Inc.·Product code GEX·1986-12-04
K863928 — TERUMO SENSIBEAD EIA FSH KITTerumo Medical Corp.·Product code CGJ·1986-12-04
K863980 — U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TESTU. S. Diagnostics, Inc.·Product code CJE·1986-12-04
K864038 — SUPERCATH I.V. CATHETERTogo Medikit Co., Ltd.·Product code FOZ·1986-12-04
K864081 — U.S. DIAGNOSTICS SERUM CHOLESTEROL TESTU. S. Diagnostics, Inc.·Product code CHH·1986-12-04
K864082 — REFLOTRON(R) ALT (GPT)Boehringer Mannheim Corp.·Product code CKD·1986-12-04
K864182 — ENTERAL ADMINISTRATION ADAPTERSBiosearch Medical Products, Inc.·Product code KNT·1986-12-04
K864188 — E-Z HOLD WITH ADHESIVE BASE.-#4065John F. Greer Co., Inc.·Product code KNX·1986-12-04
K864189 — ULTRA-GEL - #4083John F. Greer Co., Inc.·Product code EXB·1986-12-04
K864212 — IL TEST 97573-15, PLASMINOGEN ASSAYInstrumentation Laboratory CO·Product code DDX·1986-12-04
K864231 — U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TESTU. S. Diagnostics, Inc.·Product code CDT·1986-12-04
K864283 — SIMPLASTIN EXCELOrganon Teknika Corp.·Product code GJS·1986-12-04
K864298 — ZENEX MEDICAL, INC. GAUZE SPONGESZenex Medical, Inc.·Product code EFQ·1986-12-04
K864389 — CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TESTAmerican Micro Scan·Product code LJP·1986-12-04
K862087 — SANTEST 1APScientific Sales Intl., Inc.·Product code LKL·1986-12-03
K862907 — P-S MEDICAL CSF-SIPHON CONTROL DEVICEPudenz-Schulte Medical Research Corp.·Product code JXG·1986-12-03
K863190 — CHOICE CONDOMSelect Sources, Inc.·Product code HIS·1986-12-03
K863312 — SANDHILL AMSSandhill·Product code FAP·1986-12-03
K863327 — IMMPULSE IGE ASSAY REAGENTSSclavo, Inc.·Product code DGP·1986-12-03
K863394 — RAPID SPECIFIC IGE PROCEDUREAllertec, Inc.·Product code DHB·1986-12-03
K863428 — SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAGLaser Media·Product code LNK·1986-12-03
K863607 — VIBRATRON II, VIBRATION SENSITIVITY TESTERSensortek, Inc.·Product code LLN·1986-12-03
K863642 — CANDELA MODEL MDL-1 LASER LITHOTRIPTORCandela Corp.·Product code FFK·1986-12-03
K863681 — PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMKallestad Laboratories, Inc.·Product code LJP·1986-12-03
K863794 — 3M IGG4 FAST TEST PACKAGE3M Company·Product code DHB·1986-12-03
K864142 — UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVEUnited Biotech, Inc.·Product code DGC·1986-12-03
K864207 — DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONOGamma Biologicals, Inc.·Product code KTN·1986-12-03
K864329 — MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KITDlp, Inc.·Product code KNW·1986-12-03
K864473 — SEMINAL FLUID COLLECTION KIT(TM)Apex Technologies, Inc.·Product code HIS·1986-12-03
K862177 — IDEX DENTAL IMPLANTR. J. Chapman, D.M.D.·Product code DZE·1986-12-02
K863193 — SENTINEL 4 EEG ANALYZERAxon Systems, Inc.·Product code GWQ·1986-12-02
K863805 — MILLER/GALANTE TOTAL KNEE POR COATED PATELLAR DOMEZimmer, Inc.·Product code JWH·1986-12-02
K863935 — TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAYToshiba Medical Systems·Product code JAK·1986-12-02
K864010 — EMPI MODEL 712, LOGIX(TM), NMSEmpi·Product code IPF·1986-12-02
K864427 — KNEECPMInvacare Corp.·Product code BXB·1986-12-02
K864477 — FOUNDATIONS PLUS GIRDLE SUPPORT GARMENT 5000Foundations Plus, Inc.·1986-12-02
K863288 — HYDROPHILIC REPROSILDentsply Intl.·Product code ELW·1986-12-01
K863750 — HICKMAN(TM) SUBCUTANEOUS PORT W/DETACHED CATHETERC.R. Bard, Inc.·Product code LJT·1986-12-01
K863930 — VISCOPASTE ZINC PASTE BANDAGESmith & Nephew, Inc.·Product code FRO·1986-12-01
K863931 — CARBONET ODOUR ADSORBING DRESSINGSmith & Nephew, Inc.·1986-12-01
K863973 — ELM ALLERGEN DISCImmuno Nuclear Corp.·Product code DHB·1986-12-01
K864289 — MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATORAlexander Thomas, Inc.·Product code KCW·1986-12-01
K864342 — MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEXEiken Chemical Co., Inc.·Product code CFN·1986-12-01
K864397 — DISPOSABLE PHARMASEAL TEMPERATURE MONITORING PROBEAmerican Pharmaseal Div. Ahsc·Product code FLL·1986-12-01
K864459 — RAIL CLAMP EXTENSION PIECEAmerican Container Technology, Inc.·Product code FWZ·1986-12-01
K864555 — 3 RING ATTACHMENTProfessional Medical Services·Product code FMF·1986-12-01
K864556 — AQUALUBE(TM)Parker Laboratories, Inc.·Product code KMJ·1986-12-01
K862158 — AVP TELEIMAGING SYSTEMAdvanced Video Products, Inc.·Product code LMD·1986-11-28
K862165 — ELECTRONIC ULTRASOUND SCANNER, MODEL EUB-340Hitachi Medical Corp. of America·Product code IYO·1986-11-28
K863408 — EBV/VCA-CHECK(TM) ANTIGEN SLIDESDiagnostic Technology, Inc.·Product code GNP·1986-11-28
K863796 — CREATIVE CARE SYSTEMS' IV START KITAmerican Biomaterials Corp.·Product code LRS·1986-11-28
K863813 — TOXOPLASMA IGG MICROASSAYDiamedix Corp.·Product code LGD·1986-11-28
K863962 — EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95Em Diagnostic Systems, Inc.·Product code CKA·1986-11-28
K863963 — EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95Em Diagnostic Systems, Inc.·Product code CIT·1986-11-28
K864060 — MICRO-READERHyperion, Inc.·Product code JJQ·1986-11-28
K864183 — OPHTHALMIC SURGICAL INSTRUMENTSTechno Ophthalmics Intl.·Product code HNR·1986-11-28
K864230 — DIMENSION (TM) CLINICAL CHEMISTRY SYSTEME.I. Dupont DE Nemours & Co., Inc.·Product code CKE·1986-11-28
K864266 — OPHTHALMIC KNIFE & FORCEPSWestern Medical Products, Inc.·Product code HNR·1986-11-28
K864343 — BL1 (HARD CONTACT LENS)Beta Labs, Inc.·Product code HPX·1986-11-28
K864418 — LANDERS INDIRECT VITRECTOMY LENSOcular Instruments, Inc.·Product code HJK·1986-11-28
K864454 — THERMOSTABLE NUCLEASE TEST AGARDimed, Intl.·Product code JSH·1986-11-28
K861905 — PLOTTER MODEL (MP100)Madsen Electronics (Canada) , Ltd.·1986-11-26
K862744 — TELERADIOGRAPHY SYSTEME.I. Dupont DE Nemours & Co., Inc.·Product code LMD·1986-11-26
K863176 — ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+Coors Biomedical Co.·Product code LYC·1986-11-26
K863210 — VELCOM-100Waters Instruments, Inc.·Product code DPW·1986-11-26
K863647 — CARDS(TM) STREP A CATALOG NO. CR-7545Pacific Biotech, Inc.·Product code GTZ·1986-11-26
K863876 — OMNI-FILInpromas·Product code EBF·1986-11-26
K864124 — SPAND-GEL GRANULATED GELMedi-Tech Intl. Corp.·Product code KMF·1986-11-26
K864210 — MICROSELECTRON-HDR (HIGH DOSE RATE)Nucletron-Oldelft Corp.·Product code JAQ·1986-11-26
K864306 — VERINOR ALLOYDegussa Dental, Inc.·Product code EJT·1986-11-26
K864311 — STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)Clinitech, Inc.·Product code FYA·1986-11-26
K864421 — RAYLOR(TM) PERIOSTEAL ELEVATORSCedar Surgical, Inc.·Product code GEG·1986-11-26
K864424 — RAYLOR(TM) PROTECTIVE RETRACTORCedar Surgical, Inc.·Product code GAD·1986-11-26
K864426 — RAYLOR(TM) DEPTH GAUGECedar Surgical, Inc.·Product code HTJ·1986-11-26
K864474 — DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMICPlanmeca USA, Inc.·Product code EHD·1986-11-26
K862450 — MEDA 2500 T.E.N.S.Watlow/Winona, Inc.·Product code GZJ·1986-11-25
K862685 — MUSCLE MASTER (BIPOLAR STIMULATOR)Modern Systems Technology, Inc.·Product code IPF·1986-11-25
K862690 — TRAVELER LTBio-Logic Systems Corp.·Product code GWF·1986-11-25
K862844 — 7.5 MHZ LINEAR PROBE, CAT. NO. H4221HGeneral Electric Co.·Product code ITX·1986-11-25
K863230 — D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEMDextra Medical, Inc.·Product code DXG·1986-11-25
K863231 — D100 COMPUTER CARDIAC ANALYSIS SYSTEMDextra Medical, Inc.·Product code DXG·1986-11-25
K863476 — SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMOScimed Life Systems, Inc.·Product code DTZ·1986-11-25
K863578 — DERMATEC ZONE TRANSPARENT DRESSINGDermatec, Inc.·Product code NAD·1986-11-25
K863646 — ESOPHAGEAL RECTAL TEMPERATURE PROBERespiratory Support Products, Inc.·Product code FLL·1986-11-25
K863981 — STERILIZATION WRAPS #620,624,648,640,636,630,612Graham Medical Products·Product code FRG·1986-11-25
K864041 — EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95Em Diagnostic Systems, Inc.·Product code KLS·1986-11-25

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