FDA 510(k) clearances — page 1345

175,890 clearances on record, most recent first.

Clearances — page 1345

134,401–134,500 of 175,890

K874180 — COLORECTAL CANCER RISK DETECTOR (TM)Pearce Clinical Laboratories, Inc.·KHE·1988-09-30
K875258 — TOXOPLASMA GONDII IGG ELISA KITDe Ferris Laboratories, Inc.·LGD·1988-09-30
K880378 — LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001Lifecare Services, Inc.·CCL·1988-09-30
K881177 — MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORDNihon Kohden America, Inc.·GWL·1988-09-30
K881350 — CBC/CONSTAVAC BLOOD CONSERVATION SYSTEMStryker Corp.·CAC·1988-09-30
K881863 — REP GLYCO SYSTEMHelena Laboratories·LCP·1988-09-30
K882154 — HEPAX (TENS)Avl Scientific Corp.·GZJ·1988-09-30
K882211 — URISCREENDiatech Diagnostica , Ltd.·JXA·1988-09-30
K882582 — STERILE INHALATION WATER TRANSFER SETIntertech Resources, Inc.·BTT·1988-09-30
K882764 — BEAR EVC-100 CONTROLLERBear Medical Systems, Inc.·CBK·1988-09-30
K882799 — HELENA COLOCAREHelena Laboratories·KHE·1988-09-30
K882877 — JMS CERVICAL TRACTION DEVICE/HALO DEVICEJerome Medical·JEC·1988-09-30
K882888 — MULTIDAY, MODELS 8300 AND 8310Medical Devices, Inc.·GXY·1988-09-30
K882908 — SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA.Surgical Laser Technologies, Inc.·HQF·1988-09-30
K882967 — BONE FIXATION WIREBaxter Healthcare Corp·JDQ·1988-09-30
K883067 — MODIFIED SL-SERIES LINEAR ACCELERATORSPhilips Medical Systems, Inc.·IYE·1988-09-30
K883118 — ON THE SPOT CANDIDASUREMedi-Tech, Inc.·LRF·1988-09-30
K883124 — AMERLITE FREE THYROID CONTROL SERA LAN.4002Amersham Corp.·JJY·1988-09-30
K883127 — MULTI-CHANNEL STRAIN-GAGE AMPLIFIER & POWER SUPPLYAdvanced Mechanical Technology, Inc.·KHX·1988-09-30
K883222 — ISOFOR-MM (TM)Intl. Immunoassay Laboratories, Inc.·JHW·1988-09-30
K883223 — CHECK-MMIntl. Immunoassay Laboratories, Inc.·JHS·1988-09-30
K883235 — RAPIDTEST-HCG (TM)Synbiotics Corp.·DHA·1988-09-30
K883309 — MULTI-CARE CHAIRMid-Canada Medical·INM·1988-09-30
K883522 — AMERIMED ULTRASONIC SURGICAL ASPIRATION KITAmerimed US Corp.·LBK·1988-09-30
K883576 — HORIZON ORTHOPEDIC PIN PROTECTORHorizon Medical, Inc.·LYT·1988-09-30
K883593 — #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAYEcolab, Inc.·CAE·1988-09-30
K883607 — PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETERCodman & Shurtleff, Inc.·GYK·1988-09-30
K883663 — ATS BLOOD RECOVERY BAGAtrium Medical Corp.·CAC·1988-09-30
K883681 — DAS SPORT PUMP(TM)D.A. Schulman, Inc.·ILO·1988-09-30
K883693 — RESUSCITATION BAG EXHALATION FILTERIntertech Resources, Inc.·CAH·1988-09-30
K883869 — DERMTRODEWorld Precision Instruments, Inc.·GYA·1988-09-30
K883951 — MEDIUM 199 W/EBSS (CATALOG NO. 200-2037)J R Scientific·KIT·1988-09-30
K883966 — HARE COLD PACKDyna Industries, Inc.·IMD·1988-09-30
K880548 — SAFE-STRIPSMedstar, Inc.·JOJ·1988-09-29
K882054 — HYSTERO KITZinnanti Surgical Instruments, Inc.·HDP·1988-09-29
K882418 — DRY COMFORT UNDERGARMENTHealth Tec, Inc.·EYQ·1988-09-29
K882886 — PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535Medical Devices, Inc.·GXY·1988-09-29
K882887 — PROGEL(TM), MODELS 8630 AND 8635Medical Devices, Inc.·GXY·1988-09-29
K883008 — PULMONARY FORCED FLOW SYSTEM (PUFFS)Medical Associated Services, Inc.·BTY·1988-09-29
K883023 — MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUNDMentor Corp.·GDS·1988-09-29
K883227 — SKIFA, PLASTIC DISPOSABLE SYRINGEP.T. Setio Harto , Ltd.·FMF·1988-09-29
K883280 — HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIEDHologic, Inc.·KGI·1988-09-29
K883374 — BARD BIOPSY NEEDLE GUIDANCE DEVICEC.R. Bard, Inc.·KNW·1988-09-29
K883490 — ACCUFLO UF CONTROL MODULE NO. 74-0100-3National Medical Care, Medical Products Div., Inc.·FJB·1988-09-29
K883589 — GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZERGambro, Inc.·FJI·1988-09-29
K883612 — LECTROSPIRALVygon Corp.·FPA·1988-09-29
K883856 — FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPEAdvanced Surgical Products, Inc.·HBI·1988-09-29
K883857 — FIBEROPTIC WIRE PICK LIGHTPIPEAdvanced Surgical Products, Inc.·HBI·1988-09-29
K883858 — FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPEAdvanced Surgical Products, Inc.·HBI·1988-09-29
K883950 — MODIFIED TOOB-CHEQ CARBON DIOXIDE GAS ANALYZERFenem, Inc.·CCK·1988-09-29
K874818 — TENSTARHealthcheck Corp.·GZJ·1988-09-28
K881780 — VASCUCARE ANGIOPUMPVascucare, Inc.·DWB·1988-09-28
K881825 — MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATHSpectramed, Inc.·DYB·1988-09-28
K882925 — ACS SCHWARTEN XT BALLOON DILATATION CATHETERAdvanced Cardiovascular Systems, Inc.·LIT·1988-09-28
K883000 — ACS ANGIOSCOPE GUIDE WIREAdvanced Cardiovascular Systems, Inc.·LYK·1988-09-28
K883089 — 4000/4900/6000/8000/8900 ND:YAG/1700 ND:YAG C02Heraeus Lasersonics, Inc.·GEX·1988-09-28
K883149 — TEN20 CONDUCTIVEWeaver & Co.·GYB·1988-09-28
K883345 — SARNS INFANT VENOUS RESERVOIR MODEL #163873M Health Care, Sarns·DTN·1988-09-28
K883376 — STERILIZATION WRAP TYPE 22,44,77East Texas Lighthouse For the Blind·FRG·1988-09-28
K883429 — LINDSTROM CORDLESS EPILATORA Place of Health & Beauty·KCW·1988-09-28
K883684 — HERPES VIRUS CONTROL SLIDESVal Tech Diagnostics, Inc.·GQN·1988-09-28
K883685 — IMMUNO/FEBRILE ANTIGENSImmunostics Co., Inc.·GNC·1988-09-28
K883744 — MANAN HUBER STYLE INFUSION NEEDLEManan Medical Products, Inc.·FMF·1988-09-28
K883760 — STORZ MODEL 62 ENT CAMERA SYSTEMStorz Instrument Co.·FWL·1988-09-28
K883943 — CCM-1 VIDEO CAMERA SYSTEMMedical Concepts, Inc.·FTS·1988-09-28
K883944 — MEC-1 VIDEO COMBO SYSTEMMedical Concepts, Inc.·FTS·1988-09-28
K883952 — U. V. SUNLAMP 95UF-11Light Sources, Inc.·FTC·1988-09-28
K875108 — ACS CORONARY ANGIOSCOPIC CATHETERAdvanced Cardiovascular Systems, Inc.·LYK·1988-09-27
K880756 — MODEL PM-20A PHYSIOLOGICAL MONITORAdvanced Medical Systems, Inc.·DQA·1988-09-27
K880920 — LASER FLARE CELL METER FC-1000Kowa Optimed, Inc.·HJO·1988-09-27
K882568 — 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAYSpembly Medical , Ltd.·GEH·1988-09-27
K882771 — EXTRACORPOREAL MEMBRANE OXYGENATION CATHETERCook, Inc.·DWF·1988-09-27
K882809 — THYMAPADSomatics, Inc.·GXY·1988-09-27
K882892 — MEMBRANE OXYGENATORBaxter Bentley Laboratories, Inc.·DTZ·1988-09-27
K882928 — TAD INTERMEDIATE & TAD STANDARD GUIDE WIREAdvanced Cardiovascular Systems, Inc.·DQX·1988-09-27
K882981 — PTI INTRA-ART CORONARY ARTERY RETRACTION CLIPPioneering Technologies, Inc.·DWS·1988-09-27
K883320 — MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBESherwood Medical Co.·JKA·1988-09-27
K883360 — HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOMHologic, Inc.·KGI·1988-09-27
K883551 — SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #80325Bd Becton Dickinson Vacutainer Systems Preanalytic·JWY·1988-09-27
K883563 — SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPSSharplan Lasers, Inc.·GEX·1988-09-27
K883762 — BARD EMS SYSTEMS 3400 & 4400 & DUAL PAD ELECTRODEBard Electro Medical Systems, Inc.·GEI·1988-09-27
K880416 — WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEMWallach Surgical Devices, Inc.·GEH·1988-09-26
K881402 — 629V SPIROMETER, PULMONARY FUNCTION ANALYZERAmerican Electromedics Corp.·BZG·1988-09-26
K881416 — MYOTRACThought Technology , Ltd.·HCC·1988-09-26
K881632 — FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENTHuntleigh Technology, Inc.·JOW·1988-09-26
K881851 — VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METERMicro Medical, Ltd.·DSB·1988-09-26
K882315 — VIR-A-VAC EMPTYViratec Corp.·GAZ·1988-09-26
K882441 — SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATIONSurgical Laser Technologies, Inc.·HQB·1988-09-26
K882969 — VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORTGish Biomedical, Inc.·DQY·1988-09-26
K883053 — SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2AScimed Life Systems, Inc.·DTZ·1988-09-26
K883054 — SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & IIScimed Life Systems, Inc.·DTZ·1988-09-26
K883135 — PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE)Pioneering Technologies, Inc.·DWS·1988-09-26
K883201 — VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYSVital Metrics, Inc.·HBI·1988-09-26
K883330 — BASIC HEATER-COOLER UNIT, 115/100V 16-02-20Shiley, Inc.·DTR·1988-09-26
K883331 — BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10Shiley, Inc.·DTR·1988-09-26
K883332 — MAST FOR BASIC HEATER-COOLER UNIT 16-09-00Shiley, Inc.·DTR·1988-09-26
K883346 — SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13FDevices For Vascular Intervention, Inc.·LIT·1988-09-26
K883548 — SCEPTOR STREPTOCOCCUS MIC/ID PANEL #80323Bd Becton Dickinson Vacutainer Systems Preanalytic·JWY·1988-09-26
K883549 — SCEPTOR STREPTOCOCCUS MIC PANEL #80322Bd Becton Dickinson Vacutainer Systems Preanalytic·JWY·1988-09-26
K883550 — SCEPTOR STAPHYLOCOCCUS MIC #80324Bd Becton Dickinson Vacutainer Systems Preanalytic·JWY·1988-09-26

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