BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)

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

    Zio AT® device (A100A1001)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CEFALY Connected - OTC, CEFALY Connected - Rx

    FDA 510(k)
    FDA Class 2 ·Neurology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·August 24, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 24, 2013

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026