BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    XP1100 RF

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DIGIFIX EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 8, 2014

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 7, 2013

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011

    SENRI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·May 6, 2025

    SENRI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·December 24, 2025

    18 SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·August 19, 2025

    SENRI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·August 12, 2025

    18 SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·June 11, 2024

    18 SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·April 14, 2025

    SENRI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·April 11, 2025

    18 SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·May 13, 2024

    18 SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·May 27, 2026

    SENRI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·April 11, 2025

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    dS Breast 7ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    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