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

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    M-Fix Acromioclavicular Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TiN Coated Glenosphere

    FDA UDI
    FX SOLUTIONS·03701037309568·HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCRE...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575364336·Knee tibia prosthesis trial - General Instrument

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575378937·Knee tibia prosthesis trial - General Instrument

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575364343·Knee tibia prosthesis trial - General Instrument

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575378920·Knee tibia prosthesis trial - General Instrument

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575364305·Knee tibia prosthesis trial - General Instrument

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575364350·Knee tibia prosthesis trial - General Instrument

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575364312·Knee tibia prosthesis trial - General Instrument

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575364329·Knee tibia prosthesis trial - General Instrument

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575364367·Knee tibia prosthesis trial - General Instrument

    AVEA VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RDI HSFERRITIN KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 27, 2024

    AVEA VENTILATOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·July 17, 2015

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·October 8, 2014

    KAPPA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 8, 2013

    HS III PROXIMAL SEAL SYTEM 4.3MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC.·Product code DXC·June 17, 2011

    iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Recall
    Terminated ·Carefusion 211 Inc dba Carefusion·Product code CBK·September 5, 2013