BEUDAMED
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    SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123816·K-WIRE - DOUBLE TROCAR 1.25mm DIA x 125mm

    MODIFICATION TO IVENT 101

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·September 10, 2024

    ROCHE CARDIAC T QUANT 10 TESTS (COBAS)

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code MMI·March 7, 2013

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·February 15, 2011

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·August 8, 2014

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022