BEUDAMED
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    THE NEW BIO-MOORE ENDO HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984028·anteriors; shade A1; mould R 88

    PROCARE

    FDA UDI
    DJO, LLC·00190446660347·ARM SLING, CTN/POLY XLG

    MULTI CAMERA CONTROL UNIT (MCCU)

    FDA 510(k)
    FDA Class 2 ·Radiology

    AMBULATORY INFUSION SYSTEM AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BURN AID

    FDA Adverse Event
    Malfunction ·RYE PHARMACEUTICALS PTY. LTD.·Product code MGQ·April 18, 2000

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·February 28, 2013

    INTRACORPORAL LITHOTRIPTOR

    FDA Adverse Event
    Injury ·E.M.S. ELECTRO MEDICAL SYSTEMS S.A.·Product code FFK·February 4, 2011

    EMAX 2 PLUS MOTOR

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

    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