BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    FINE-JECT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Polystar Selection EDITION HD

    FDA UDI
    Merz Dental GmbH·D7091983067·posteriors; shade B4; size L; lower jaw

    Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ARCHITECT C4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·July 31, 2018

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 16, 2014

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·February 28, 2013

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·February 4, 2011

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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