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

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    DIOLASE

    FDA 510(k)
    FDA Class 1 ·Radiology

    MOR® Scan Body

    FDA UDI
    STERNGOLD DENTAL LLC·00841549118388·The Scan Body acts as a digital impression post...

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    FDA UDI
    Biomet Orthopedics, LLC·00880304469471·

    600 OR 1200 ML. ENTERAL BAG ADMINISTRATION SET

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

    SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ESSURE

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code KNH·October 9, 2014

    REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 24.5X25

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 25, 2020

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 22, 2010

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014

    SUNBEAM

    FDA Adverse Event
    Malfunction ·JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS·Product code IRT·December 4, 2012

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 12, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·July 20, 2016

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·May 13, 2020

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·February 10, 2020

    Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·September 23, 2020

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015