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

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    SMA II

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LANEX Regular Screens

    FDA UDI
    CARESTREAM HEALTH, INC.·60889971771339·PR 24X30CM LANEX SCR REG C2

    ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath

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

    SPIROPERFECT

    FDA Adverse Event
    Malfunction ·MEDIKRO OY·Product code BZG·August 11, 2023

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 24, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 4, 2012

    UNI-VENT

    FDA Adverse Event
    Malfunction ·IMPACT INSTRUMENTATION, INC·Product code CBK·July 21, 2010

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026