BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    PARATHYROID HORMONE MID-MOLECULE RIA-KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BETA THALQUIK COLUMN #5341

    FDA 510(k)
    FDA Class 2 ·Hematology

    X°Port Lung Preservation System; X°Port Lung Preservation Solution

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

    UNKNOWN SZ. 28 DURALOC LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·June 2, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 26, 2012

    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code ESW·September 24, 2010

    8100 ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 10, 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