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

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    MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tornier Latitude

    FDA UDI
    TORNIER, INC.·00846832020034·SLAPHAMMER ATTACHMENT

    TriVerse Femoral Component CR

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215100209·

    LIGHTLAS 532 PHOTOCOAGULATOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP

    FDA 510(k)
    FDA Class 2 ·Immunology

    ZEPHIR® ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·April 24, 2014

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 18, 2011

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·November 2, 2022

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·January 3, 2017

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·September 20, 2013

    PEN NDL 31GA 8MM 100 BX 1200 USA

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·April 17, 2025

    MENTOR

    FDA Adverse Event
    Injury ·MENTOR·Product code FTR·March 27, 2013

    E-LUMINEXX VASCULAR STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code NIO·March 22, 2011

    CONTOUR TEST STRIPS (10)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·April 15, 2008

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·October 12, 2011

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·March 8, 2023

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·February 18, 2025

    ERBE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code GEI·July 27, 2022

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012