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

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    ARTHROTEK INTERFERENCE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 125

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 7, 2012

    OsteoCool RF Ablation System

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

    INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT

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

    SUPRACONDYLAR NAIL T2 SCN 10 X 200 MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS ¿ KIEL·Product code HSB·July 17, 2012

    SPACEMAKER STRUCTURAL BALLOON TROCAR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GCJ·June 23, 2014

    PC HYBRID GLENOID POST- POLY

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·February 28, 2013

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code LFX·February 9, 2011

    MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·February 19, 2019

    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