BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    BLUEPRINT Patient Specific Instrumentation

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LATERAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNSPECIFIED PRIMARY PLUM SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·October 3, 2024

    REVEAL LINQ

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code DSI·October 10, 2014

    STELLARIS MICRO INCISION VACUUM PACK

    FDA Adverse Event
    Injury ·BAUSCH & LOMB, INC.·Product code HQC·June 6, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·July 8, 2011

    UNSPECIFIED PRIMARY PLUM SET CLAVE PORT, CLAVE Y-SITE, SECURE LOCK

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·November 24, 2024

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018