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

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    BODEN WHEELCHAIR DRAINAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613023409·Plastic Stitch Scissors, Straight, Flat Round S...

    Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DIASUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·TRIVASCULAR, INC·Product code MIH·June 11, 2014

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 14, 2013

    RETRACTOR RINGS

    FDA Adverse Event
    Malfunction ·LONE STAR MEDICAL PRODUCTS·Product code GAD·November 15, 2010

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015