BEUDAMED
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    CHAIT CECOSTOMY CATHETER

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

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756023627·ELASTIC BANDAGE

    DEPUY SIGMA CR-F FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Catalyst CSR Press-Fit Humeral Components

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERSAPORT PLUS V2 11M TROCAR W/FIXATION

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GCJ·June 23, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 28, 2013

    BIOMEDICUS ONE PIECE FEMORAL CANNULA KIT

    FDA Adverse Event
    Injury ·MEDTRONIC PERFUSION SYSTEMS·Product code DQY·February 1, 2011

    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