BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANGIOMED URETER DIATION SETS

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

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2014

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·October 5, 2010

    CARELINK PROGRAMMER 2090X

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code NVZ·December 10, 2012

    STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

    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