BEUDAMED
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    CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Oticon

    FDA UDI
    Oticon A/S·05707131261335·H11, BTE 13 WL 85 TC

    COLOR LCD DISPLAY, MODEL RADIFORCE R22

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTHREX UNIVERS II SHOULDER PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LINER: CC E CC LIGHT FLAT PE HC LINER 36 / E

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 27, 2020

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 29, 2013

    DST SERIES EEA ORVIL 25MM DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN·Product code GDW·June 14, 2011

    RESOLUTION CLIP DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MND·August 22, 2008

    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016