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

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    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PEEK Corpectomy

    FDA UDI
    Nuvasive, Inc.·00887517623027·PEEK Corp Core, Ø12x12mm

    Key Surgical K-Wires and Steinmann Pins

    FDA UDI
    KEY SURGICAL, INC.·00849771012795·K-Wires, Double diamond, .045-inch (1.1mm) diam...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293043·

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771049415·K-Wires, Double diamond, .045-inch (1.1mm) diam...

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659484559·K-Wire w. double end lanzet point _x000D_...

    K-Wire w. double end lanzet point 1.1mm/229mm, 6 pcs./unit

    FDA UDI
    mahe medical gmbh·EMAHKM712120·K-Wire w. double end lanzet point 1.1mm/...

    Tx™

    FDA UDI
    INNO Holdings, Inc.·M711LS39712120·Ti 6Al 4V (ELI)

    ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AirFit N20

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PRECISION QID

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 26, 2017

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 26, 2017

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 1, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·January 26, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 31, 2014

    STRONG ARM

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HXD·October 10, 2014

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017