BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    DRILL, DENTAL

    FDA 510(k)
    FDA Class 1 ·Dental

    ACUMED

    FDA UDI
    Acumed LLC·10806378052132·2.8mm Cleaning Stylet

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209137398·

    MODIFICATION TO PASCO MIC AND MIC/ID PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LUTE-IT II VENEER CEMENT, MODEL NO6

    FDA 510(k)
    FDA Class 2 ·Dental

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 11, 2014

    TECNIS

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·October 23, 2012

    MAGIC 3 FEMALE INTERMITTENT CATHETER

    FDA Adverse Event
    Malfunction ·ROCHESTER MEDICAL CORP·Product code KOD·May 27, 2015

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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 Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

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