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

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    CHARTER GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970546·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970553·

    BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR

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

    SIROCCO THERMAL REGULATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR

    FDA Adverse Event
    Malfunction ·INOGEN, INC.·Product code CAW·September 28, 2023

    TARGET DEVICE 300X160MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·March 2, 2012

    UNKNOWN MODULAR HEAD COMPONENT 28MM+6MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·September 28, 2022

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 21, 2013

    ASR ACETABULAR CUPS 60

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 3, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 14, 2008

    Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 8, 2016

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024