BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    SKINTEMP

    FDA 510(k)
    FDA Unclassified ·Unknown

    EBERLE

    FDA UDI
    Eberle GmbH & Co. KG·04050052023478·Reamer, AO Synthes / ASIF / PROTEK

    Blood Pressure Monitor(Model:Y30001)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UNK MAILLEFER

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·November 8, 2022

    CLAVE CONNECTOR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·November 18, 2010

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·January 14, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 3, 2014

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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