BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    FOUNDATION

    FDA 510(k)
    FDA Class 2 ·Dental

    DIRECT TIBC CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    2.0/2.4 CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·October 8, 2013

    ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

    FDA Adverse Event
    Malfunction ·INFUTRONIX, LLC·Product code FPA·November 21, 2018

    ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

    FDA Adverse Event
    Malfunction ·INFUTRONIX, LLC·Product code FPA·November 21, 2018

    ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

    FDA Adverse Event
    Malfunction ·INFUTRONIX, LLC·Product code FPA·November 21, 2018

    ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

    FDA Adverse Event
    Malfunction ·INFUTRONIX LLC·Product code FPA·October 30, 2017

    CD HORIZON

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 11, 2020

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·December 29, 2010

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 8, 2013

    CARDIAC

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC·Product code JAA·May 9, 2008

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·July 6, 2020

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·July 29, 2025

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018