FDA 510(k) clearances — page 1419

176,637 clearances on record, most recent first.

Clearances — page 1419

141,801–141,900 of 176,637

K864374 — ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEMSherwood Medical Co.·Product code CAC·1987-03-16
K864419 — LIFEWATCH(R) PORTABLE MONITORING SYSTEMLifewatch Systems, Inc.·Product code BZQ·1987-03-16
K864436 — STAVIP 3000Roseburg SA·Product code JJN·1987-03-16
K864719 — PFLEX EM(TM) (EXERCISE MONITOR)Health Products, Inc.·Product code BWF·1987-03-16
K864843 — HORIZON 1100 CARDIAC MONITORMennen Medical, Inc.·Product code DPS·1987-03-16
K864866 — RESUBMISSION OF THE KLEERZIT REAGENTAdvanced Biomedical Methods, Inc.·Product code JKA·1987-03-16
K864910 — MEVACHECKMagus Microcontrollers, Inc.·Product code IYE·1987-03-16
K864955 — CYTOSCANImage Recognition Systems , Ltd.·Product code LNJ·1987-03-16
K865104 — IQ FTI IMMUNOASSAYBd Becton Dickinson Vacutainer Systems Preanalytic·Product code CEC·1987-03-16
K870027 — HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZERSalter Labs·Product code CCQ·1987-03-16
K870109 — RMI VENOUS DRAINAGE CANNULAResearch Medical, Inc.·Product code DWF·1987-03-16
K870171 — (MERIFLUOR)TM-CRYPTOSPORIDIUMMeridian Diagnostics, Inc.·1987-03-16
K870189 — ARIES TAPERED SHEATHAries Medical, Inc.·Product code DYB·1987-03-16
K870363 — HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHODTrace Scientific , Ltd.·Product code KHG·1987-03-16
K870377 — ABUSCREEN (R) EIA CANNABINOIDSRoche Diagnostic Systems, Inc.·Product code LDJ·1987-03-16
K870378 — ABUSCREEN (R) EIA BARBITURATERoche Diagnostic Systems, Inc.·Product code DIS·1987-03-16
K870402 — MOBILIMB HAND EXERCISERBiodynamic Technologies, Inc.·Product code BXB·1987-03-16
K870507 — GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULAResearch Medical, Inc.·Product code DWF·1987-03-16
K870511 — CHART-TYPE MICRO HEMATOCRIT TUBE READERNorfolk Scientific, Inc.·Product code JPI·1987-03-16
K870619 — ACCELOGRAPHBiometer Intl. A/S·Product code BXN·1987-03-16
K870755 — CHALLENGER DOSIMETERSalter Labs·Product code CCQ·1987-03-16
K870818 — BODYSCANSiemens Gammasonics, Inc.·Product code IYX·1987-03-16
K861679 — SHBG IRMA KITFarmos Group , Ltd.·Product code CDZ·1987-03-13
K862766 — EPISON, ALERTING SYSTEM FOR EPILEPTICSZygo Industries, Inc.·Product code LEL·1987-03-13
K863245 — SYVA ETS SYSTEMSyva Co.·Product code JJF·1987-03-13
K864174 — UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVEUnited Biotech, Inc.·Product code JHI·1987-03-13
K864313 — CO2 REAGENT SETHf Scientific, Inc.·Product code CIE·1987-03-13
K864515 — RING UPM TOTAL HIP REPLACEMENTDowns Surgical , Ltd.·Product code KWA·1987-03-13
K864543 — SUNGLASSESImage of Hawaii·Product code HQY·1987-03-13
K864586 — S&W ELECTRODE TYPES 888, 844, 988 AND 944S & W Medico Teknik·Product code DRX·1987-03-13
K864751 — TDXR CANNABINOIDSAbbott Laboratories·Product code LDJ·1987-03-13
K864872 — MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZERMedica Corp.·Product code JGS·1987-03-13
K864968 — BACPAC (TM), MODEL 6500Medical Devices, Inc.·Product code GZJ·1987-03-13
K865011 — PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVERLabeltape Meditect, Inc.·Product code DRX·1987-03-13
K865071 — THYROID STIMULATING HORMONE (TSH IRMA) RIA KITImmuchem Corp.·Product code JLW·1987-03-13
K870025 — AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTSAmerican Research Products Co.·Product code KMS·1987-03-13
K870030 — THE SCREENER GSI 55 ABR SCREENERGrason-Stadler, Inc.·Product code GWJ·1987-03-13
K870106 — COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTSDiagnostic Products Corp.·Product code JHI·1987-03-13
K870166 — PLATFORM MATTRESS W/DISPOSABLE BEDPAN BAGGeorge C. Kuhn·Product code FNJ·1987-03-13
K870229 — HEARING AID TEST SYSTEM MODEL HAT 1000Madsen Electronics (Canada) , Ltd.·Product code ETW·1987-03-13
K870242 — INTERMATE(TM)Infusion Systems Corp.·Product code FRN·1987-03-13
K870324 — #014460-120 3-WAY & #014461-120 4-WAY STOPCOCKClinical Connections, Inc.·Product code FMG·1987-03-13
K870351 — EZ COMPLEMENT REAGENTS, 78N2212Diamedix Corp.·Product code DHL·1987-03-13
K870474 — INSTAJECTPavel Jordan & Associates, Inc.·Product code KZH·1987-03-13
K870522 — DEPEND UNDERPADKimberly-Clark Corp.·Product code KME·1987-03-13
K870631 — FAST GLUCOSESclavo, Inc.·Product code CGA·1987-03-13
K870632 — FAST URIC ACIDSclavo, Inc.·Product code KNK·1987-03-13
K870691 — DAHLBERG MODEL UV TRIMLINE IN-THE-EAR HEARING AIDDahlberg Electronics, Inc.·Product code ESD·1987-03-13
K870768 — AC ADAPTER ACCESSORY, PRODUCT CODE 600123ADeltec Systems, Inc.·Product code FRN·1987-03-13
K870776 — RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINTReagents Applications, Inc.·Product code CEO·1987-03-13
K870777 — PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZERKone Instruments, Inc.·Product code JJF·1987-03-13
K870795 — EMG ELECTRODES AND EXTENSION CORDSNihon Kohden America, Inc.·Product code IKT·1987-03-13
K870827 — INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENTIntersect Systems, Inc.·Product code CDT·1987-03-13
K870828 — INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENTIntersect Systems, Inc.·Product code CHH·1987-03-13
K870844 — SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTORWarsaw Orthopedic, Inc.·Product code HWB·1987-03-13
K870846 — SCHULTZ MP COMPONENT PUNCHWarsaw Orthopedic, Inc.·Product code HWP·1987-03-13
K870847 — SCHULTZ PHALANGEAL COMPONENT DRIVERWarsaw Orthopedic, Inc.·Product code HWR·1987-03-13
K870848 — SCHULTZ METACARPAL COMPONENT DRIVERWarsaw Orthopedic, Inc.·Product code HWR·1987-03-13
K870964 — ESI-1002 SYSTEM AND DC100S/C50M-P TRANSDUCERElscint, Inc.·Product code IYO·1987-03-13
K863877 — BENZODIAZEPINE ENZYME IMMUNOASSAY KITGeneral Diagnostics·Product code JXM·1987-03-12
K864110 — RICKETTSIAL IGG AND IGM IFA KITHillcrest Biologicals·Product code GPN·1987-03-12
K864228 — APO B., IMMUNOTURBIDIMETRIC ASSAYIntl. Diagnostic Laboratories, Ltd.·Product code MSJ·1987-03-12
K864438 — BECKMAN EPSILON(TM) LIPASE TEST KITBeckman Instruments, Inc.·Product code CET·1987-03-12
K864539 — MODIFIED IMAGEN(TM) CHLAMYDIA TESTBoots-Celltech Diagnostics, Inc.·Product code LJP·1987-03-12
K864658 — IQ FREE T4 IMMUNOASSAYBd Becton Dickinson Vacutainer Systems Preanalytic·Product code CEC·1987-03-12
K864668 — ANA TEST KITVal Tech Diagnostics, Inc.·Product code LKJ·1987-03-12
K864714 — INFRALUX HEAT LAMPInfralux International, Inc.·Product code ILY·1987-03-12
K864737 — NIBP NON-INVAS. BLOOD PRESS. CART. MODEL 88 35 340Siemens Medical Solutions USA, Inc.·Product code DXN·1987-03-12
K864766 — SOUNDTEK MODEL UT-4700Soundtek, Inc.·Product code IMJ·1987-03-12
K865081 — AFFINITY(TM) HTSH IMMUNIT(TM)Bd Becton Dickinson Vacutainer Systems Preanalytic·Product code JLW·1987-03-12
K865105 — AFFINITY(TM) SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic·Product code JJE·1987-03-12
K870151 — TOTAL/IGE THEOPHYLLINE CONTROL SERA3M Company·Product code JJX·1987-03-12
K870570 — FERRITIN MAB SOLID PHASE COMPONENT SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic·Product code DBF·1987-03-12
K870832 — OXY-THERMM.D. Intl., Inc.·Product code IMD·1987-03-12
K853194 — ERA-20Biotronik Sales, Inc.·Product code DTE·1987-03-11
K863630 — AUSTENAL ACUPAC 20 DENTURE BASE MATERIALAustenal Dental, Inc.·Product code EBI·1987-03-11
K863674 — TRACETS 2000/ELECTRODESLectec Corp.·Product code DRX·1987-03-11
K864279 — SPACELABS MODEL 90419 PULSE OXIMETER MODULESpacelabs, Inc.·Product code DQA·1987-03-11
K870024 — PONTALLOR 4 DENTAL ALLOYDegussa Dental, Inc.·Product code EJT·1987-03-11
K870053 — TORQUEDRIVER WRENCHJerome Medical·Product code HXC·1987-03-11
K870338 — MODEL MS-II MINISTIMLife-Tech Intl., Inc.·Product code BXN·1987-03-11
K870350 — ESCORT EC CUSTOM IN-THE-EAR HEARING AIDHearing Tech, Inc.·Product code ESD·1987-03-11
K870380 — MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03Hewlett-Packard Co.·Product code DPS·1987-03-11
K870434 — MODEL 350 WIRELESS BICROS/MULTICROS HEARING AIDSTelex Communications, Inc.·Product code ESD·1987-03-11
K870435 — MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AIDTelex Communications, Inc.·Product code ESD·1987-03-11
K870503 — HEARING AID, UNITRON MODEL UM60Unitron Industries, Inc.·Product code ESD·1987-03-11
K870845 — WARSAW ORTHOPEDIC POINTED REAMERWarsaw Orthopedic, Inc.·Product code HTO·1987-03-11
K861543 — CARDIOMAX-IIColumbus Instruments Intl. Corp.·Product code DXG·1987-03-10
K863223 — DIMENSION-WBGDimension Diagnostics·Product code CGA·1987-03-10
K864731 — OCEAN SCIENTIFIC VDRL TESTOcean Scientific, Inc.·Product code GMQ·1987-03-10
K864758 — DIASONICS SPA 5.O 27MM PROBEDiasonics, Inc.·Product code ITX·1987-03-10
K864812 — DIASONICS SPA 3.5 MHZ, 30MM PROBEDiasonics, Inc.·Product code ITX·1987-03-10
K864858 — LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTORBiomedical Concepts, Inc.·Product code BZT·1987-03-10
K864874 — SEGURA DRETLER BASKETVan-Tec, Inc.·Product code FFL·1987-03-10
K864942 — BICARBONATE MIXING SYSTEMMorris Tool , Ltd.·Product code KPO·1987-03-10
K864970 — TERUMO DENTAL NEEDLESTerumo Medical Corp.·Product code DZM·1987-03-10
K864985 — DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCEMedac, Inc.·Product code DRO·1987-03-10
K865030 — CARDIOFAX-V ECG-8240ANihon Kohden America, Inc.·Product code DSI·1987-03-10
K865032 — CARDIOFAX-V ECG-834OANihon Kohden America, Inc.·Product code DSI·1987-03-10
K865057 — TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAYHybritech, Inc.·Product code JHI·1987-03-10

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