BEUDAMED
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    DENALI 501CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506088001·UTERINE DILATOR, HEGAR, 3.5MM DIAMETER

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221037480·Unitek(TM) Bicuspid Band General Purpose Narrow...

    HOVERJACK AIR PATIENT LIFT DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DUSIMETRY CHECK

    FDA 510(k)
    FDA Class 2 ·Radiology

    EXTENSION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 1, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 4, 2012

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017