BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    IMATION TRIMATIC DIGITAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984252·anteriors; shade B1; mould R 87

    CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·October 27, 2011

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·October 27, 2011

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 18, 2011

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPAEDIC INC.·Product code KWP·October 8, 2009

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    WARSAW ORTHOPEDIC, INC.·Product code KWP·May 20, 2011

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    WARSAW ORTHOPEDIC, INC.·Product code KWP·May 20, 2011

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    WARSAW ORTHOPEDIC, INC.·Product code KWP·May 20, 2011

    RIATA ST PASSIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 10, 2011

    NONE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code FRN·December 18, 2013

    ARROW EXT DWELL CATH DEVICE 20GAX6CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code FOZ·August 29, 2018

    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