BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    Threshold™ V2 Pedicular Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169595743·TRIAL 2170255 O25 IB 20MM 0 DEG 10X55

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·January 23, 2002

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 2, 2022

    SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·June 14, 2013

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 20, 2011

    AUTOCAT 2 WAVE JAPANESE

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DSP·September 11, 2008

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024