BEUDAMED
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    SIDE CUTTING PARALLEL ACTION PLIERS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Quickie(r) Q700-UP M

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 2, 2014

    4.0MM CANNULATED SCREW LONG THREAD/46MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HWC·December 13, 2012

    SOFTHEAT

    FDA Adverse Event
    Other ·KAZ INC·Product code IRT·October 12, 2010

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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