BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    SYNCHRON SYSTEMS METHADONE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    artegral HD

    FDA UDI
    Merz Dental GmbH·D7091973069·posteriors; shade B2; size XS; lower jaw

    MODIFICATION TO AVEA VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFIED VISIO-SEAL

    FDA 510(k)
    FDA Class 2 ·Dental

    VIASYS

    FDA Adverse Event
    Malfunction ·CAREFUSION 207, INC·Product code CBK·October 26, 2009

    UNIVERSAL KEY CHUCK ATTACHMENT W/KEY 1000

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL S.A.·Product code HAB·April 29, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 21, 2013

    HOMECHOICE, DOMESTIC 120V

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·January 28, 2011

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC·Product code CBK·October 27, 2009

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC.·Product code CBK·October 27, 2009

    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

    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 Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·October 9, 2013