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

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    LYPHOCHEK(R) FRUCTOSAMINE CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PAQ.210X280X250.MORT.ELI380

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763090472·

    NMI PICC III

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADAPTER SLEEVES 12/14 +8

    FDA Adverse Event
    Malfunction ·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 17, 2013

    ADAPTA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·December 13, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 9, 2014

    RT-5100 Refractor, a component of the Epic-5100 System.

    FDA Enforcement
    Class III ·Terminated·Nidek Inc.·December 26, 2018

    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