BEUDAMED
    13 results · 17ms · Sources: EU EUDAMED, US FDA

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    ROCHE REAGENT FOR BUN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    T-PIECE, 22M, 22M/15F, 22M, WITH ONE-WAY VALVES

    FDA UDI
    Intersurgical Incorporated·05030267057207·T-PIECE, 22M, 22M/15F, 22M, WITH ONE-WAY VALVES

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694041102·ExtremiFuse Organizer Block

    OMNI Knee

    FDA UDI
    Omni Life Science, Inc.·00841690111764·Modular Tibia Pegs

    Ophthalmic Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668106488·DRESSING FORCEPS DELICATE STRAIGHT

    TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    INFUSION CATHETER W/SIDE HOLES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIGASURE ADVANCE

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE·Product code GEI·January 15, 2013

    CONFIENT

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 10, 2011

    ACS HI-TORQUE FLOPPY II GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·July 23, 2014

    Vanguard XP Tibial Tray 75 mm Item # 195251

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code FRN·February 14, 2012

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012