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

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    Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551082416·Hook, 90°, sharp, 3 mm, length 17.5 cm

    Penumbra System (Reperfusion Catheter RED 62)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 27, 2023

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Malfunction ·COVIDIEN (IRVINE)·Product code OUT·February 12, 2015

    VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER

    FDA Adverse Event
    Injury ·DIGITAL ANGEL CORPORATION/ JAMM TECHNOLOGIES·Product code NRV·August 5, 2022

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 6, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·September 2, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·FREEDOM DESIGNS INC·Product code IOR·July 18, 2013

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code OUT·February 12, 2015

    Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.

    FDA Enforcement
    Class II ·Terminated·Alcon Research Laboratories Ltd.·March 6, 2019