BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Radiology

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07310K1190140·Tray Insert 6, Cosmo MIS,Arcamed

    BOND BONE

    FDA 510(k)
    FDA Class 2 ·Dental

    JOURNEY BCS KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·July 17, 2024

    0001825034-2019-01254

    FDA Adverse Event
    Malfunction ·March 19, 2019

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 21, 2013

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code MTA·July 19, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 21, 2014

    MENTOR SILTEX ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·January 31, 2018

    191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·June 3, 2024

    VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc·May 25, 2022