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

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    Digital Electrocardiograph

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707017134·CALIBRA 1ST MOL BANDS LOWER KIT LR

    SETx COVER PLATE INSERTER 9-12mm

    FDA UDI
    XENCO MEDICAL LLC·B064XMPH11600921·

    Coaxial needle

    FDA UDI
    Möller Medical GmbH·04260277175351·

    QUICKCAT EXTRACTION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CORVUS RADIATION THERAPY PLANNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    TIBIAL INSERT FIXED SPHERE FLEX #2/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 4, 2018

    AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·February 6, 2013

    AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code KPQ·May 24, 2012

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·October 10, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 10, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011

    AdvantageSim MD versions 7.4 through 7.6, Model 5160092. AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code KPQ·February 2, 2009

    MAGNETOM Verio Dot. Model Number: 10684333.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025