BEUDAMED
    8 results · 34ms · Sources: EU EUDAMED, US FDA

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    DYNATECH MR 300 MANUAL MICROELISA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    THEOFAST TEST KIT FOR QUANTITATIVE THEO

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DERATA MEDI-JECTOR PRO

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYMBIQ SINGLE CHANNE

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 18, 2014

    THINPREP IMAGING SYSTEM

    FDA Adverse Event
    Other ·HOLOGIC, INC.·Product code MKQ·October 12, 2010

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    LAND AMERICA HEALTH & FITNESS·Product code FSA·December 14, 2012

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024