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

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    AEGIS & AEGIS II SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2025

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471122826·K-WIRE - DOUBLE TROCAR 0.7mm DIA x 150mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450238226·

    SENOVA(R) BLOOD GLUCOSE MONITOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FIRST CHOICE & FIRST CHOICE PLUS

    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·May 3, 2013

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 3, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 18, 2011

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022