BEUDAMED
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    PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710400520380·Anterior Dome Osteotomy Guide, 52mm x 38mm

    SPI ONETIME DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    JAS URIC ACID LIQUID REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VERSAJET II

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW·Product code FQH·April 1, 2013

    PSI KIT: 8.5 FR

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL, INC.·Product code KGZ·March 2, 2011

    OSS FEMORAL ANCHOR PLUG

    FDA Adverse Event
    Malfunction ·BIOMET, INC.·Product code JWH·May 5, 2008

    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