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

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    ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971390·

    YA-MAN LASER 21

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

    CORELEADER HEMO-PAD MODEL CPII 02030

    FDA 510(k)
    FDA Unclassified ·Unknown

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 1, 2014

    APEX?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·May 29, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 17, 2011

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015