BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    Masimo MightySat Rx Fingertip Pulse Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AccuQuest

    FDA UDI
    Bernafon AG·05711584079201·AQ CO9 MNR, 2.4G NFM PB MAC/MSIL ACCUQ

    STRAUMANN MEMBRAGEL

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDINOL X-SUIT NIR BILIARY METALLIC STENT

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

    PERFORMANCE PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 21, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 28, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code LFR·September 22, 2008

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021