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

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    KOGENT BIPOLAR FORCEPS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973875·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973790·

    REFORM PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CIV-OB (PLUS)

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

    INION OTPS BIOABSOBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·November 18, 2014

    INION OTPS BIOABSOBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·May 14, 2015

    INION OTPS BIOABSORBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·March 19, 2015

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 21, 2013

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·September 26, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011

    INION OTPS BIOABSORBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·June 5, 2015

    30K FSI-SLI-10S INSERT,PKD

    FDA Adverse Event
    Malfunction ·DENTSPLY LLC·Product code ELC·April 23, 2025

    Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 14, 2016

    Philips Brilliance 64 computed tomography x-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020