BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    Reprocessed ViewFlex™ Xtra ICE Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ECG Module(AHA)

    FDA UDI
    SAMSUNG MEDISON CO., LTD.·08806167712532·

    Oticon

    FDA UDI
    Oticon A/S·05707131339140·SIYA 2, MINIRITE T 312 2.4G C092

    CETRA

    FDA UDI
    Orthofix US LLC·18257200120680·4-LEVEL PLATE ASSEMBLY, 78MM

    SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AOS PROXIMAL HUMERAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AEQ REVERSED II GLENOID SPHERE D.42MM CENTER D 25MMBASEPLATE

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code PHX·October 2, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 21, 2025

    CETRA

    FDA Adverse Event
    Injury ·ORTHOFIX·Product code KWQ·September 18, 2024

    CETRA

    FDA Adverse Event
    Injury ·ORTHOFIX·Product code KWQ·September 18, 2024

    MONACO

    FDA Adverse Event
    Malfunction ·ELEKTA INC.·Product code MUJ·July 28, 2021

    SHUNT SENSOR SYS500

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·June 21, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014

    AEQ REV II GLENOID BASEPLATE DIA 25MM LONG POST

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·January 7, 2025

    MONACO

    FDA Adverse Event
    Malfunction ·ELEKTA INC·Product code MUJ·August 25, 2021

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024