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

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    MICROLAB M-MICROPROCESSOR DILUTER/DISP

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER

    FDA 510(k)
    FDA Class 2 ·Dental

    CLEARFIL ST OPAQUER

    FDA 510(k)
    FDA Class 2 ·Dental

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 9, 2014

    BIORAPTOR 2.9 AB SUTURE ANCHROR WITH 2 ULTRABRAID SUTURE

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW MANSFIELD MANUFACTURING SITE·Product code MAI·October 23, 2012

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·May 26, 2015

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    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