BEUDAMED
    10 results · 24ms · Sources: EU EUDAMED, US FDA

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    AMIELLE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Polystar Selection EDITION HD

    FDA UDI
    Merz Dental GmbH·D7091983045·posteriors; shade B1; size M; lower jaw

    A-DEC PRIORITY 1005 CHAIR

    FDA 510(k)
    FDA Class 1 ·Dental

    Eclipse 2L

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024218338·

    TPRLC 133 T1 PPS HO 11X142MM 2MM T1

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWL·March 14, 2022

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·February 28, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·February 4, 2011

    SYSTEM 6 NON STERILE BATTERY

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·August 6, 2014

    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