BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    DSL BETA 2 MICROGLOBULIN (DSL 6100)

    FDA 510(k)
    FDA Class 2 ·Immunology

    Malibu

    FDA UDI
    Seaspine Orthopedics Corporation·10889981080969·Tap 5.0mm (for 5.5mm Screw)

    SPEACELABS MULTIGAS MODULE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·January 11, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 2, 2010

    INCEPTA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 3, 2014

    SYRINGE 50ML 18G 1-1/2IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·March 16, 2020

    Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM70SSA) Product Usage: Disposal system for counting of used surgical blades and needles.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·April 3, 2013

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

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

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

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