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

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    Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REDSENSE-ALARM UNIT AND SENSOR

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

    PATRIOT TRANSCONTINENTAL LLIF SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWERGLIDE MEDLINE CATHETER, 20G 8CM

    FDA Adverse Event
    Injury ·BARD ACCESS SYSTEMS INC.·Product code FOZ·October 17, 2014

    TRUEPATH?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code DQX·June 27, 2013

    PROTIME MICROCOAGULATION SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code GKP·July 13, 2011

    MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)

    FDA Enforcement
    Class II ·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023