BEUDAMED
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    Powered Wheelchair DYW30A(D09)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LATITUDE ELBOW PROTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IFUSE IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·SI-BONE, INC.·Product code OUR·June 22, 2018

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 14, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·June 22, 2011

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    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