BEUDAMED
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    DEKA SMARTPERIO

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

    DEKA SMARTPERIO

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code NVK·December 11, 2024

    RIGIDFIX

    FDA UDI
    DEPUY MITEK, LLC·10886705002894·RIGIDFIX Tibial Locking Ring 8.5mm

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180124752·5MM DIA., 36CM, INSULATED CONE TIP ELECTRODE, S...

    BIOMET CEMENTED CUP HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304450097·

    Biomet® Cemented Cup Hip System

    FDA UDI
    Biomet Orthopedics, LLC·00887868343315·

    Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.

    FDA Recall
    Terminated ·Envoy Medical Corporation·Product code OAF·June 28, 2018

    MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMPLATZER VASCULAR PLUG 4

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNKNOWN_TRAUMA_AND_EXTREMITY_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER TRAUMA SELZACH·Product code HTY·October 30, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    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