BEUDAMED
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    DuraFuse Clip and Applier System

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526799448·MANUMED ACTIVE WRIST RIGHT SAND M

    4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HTW·August 24, 2015

    SENTRYSUITE PRODUCT LINE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO:APEX MEDICAL IF-4100

    FDA 510(k)
    FDA Class 2 ·Neurology

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 17, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN - BENNETT CORP.·Product code CBK·October 22, 2008

    ALIGN URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Other ·BARD SHANNON LIMITED·Product code OTN·July 3, 2013

    NANOZOOMER S360 (THIS IS AN IVDD PRODUCT, NOT SOLD IN THE U.S.)

    FDA Adverse Event
    Malfunction ·HAMAMATSU PHOTONICS K.K, SYSTEMS DIVISION,·Product code PSY·June 5, 2023

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019