BEUDAMED
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    AMO PHACOFLEX II INTERSECTION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    EMERALD

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·July 6, 2016

    P.F.C. SIGMA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295236276·P.F.C. SIGMA POSTERIOR-LIPPED TIBIAL INSERT TRI...

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471149816·K-WIRE - DOUBLE TROCAR FULLY THREADED 1.2mm DIA...

    DERMATHERAPY, MODEL 22216

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TEFLON COATED RESECTOSCOPE SHEATH

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

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 14, 2013

    HI-TORQUE PILOT GUIDE WIRE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code DQX·January 14, 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