BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    ERGOTEST 40 & 45

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BD Alaris Infusion System with Guardrails Suite MX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDCARE INCISION & DRAINAGE TRAY

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code FNG·November 23, 2012

    CLEO® 90 INFUSION SET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL·Product code FPA·August 3, 2016

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·June 3, 2015

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Injury ·HEART VALVES SANTA ANA·Product code NPT·October 27, 2021

    Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

    FDA Enforcement
    Class II ·Terminated·Isopure Corp·September 21, 2022

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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