BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    PLATELIA ASPERGILLUS EIA, MODEL 62793

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70606411·Sprint II Bracket Roth .018" 20 Brackets 3 w. hook

    DYSPLASIA INSERT 48/28

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LXH·October 11, 2019

    CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GE CT-PET SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code NIQ·February 5, 2024

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC.·Product code CBK·March 28, 2013

    MP30 INTELLIVUE PATIENT MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·April 8, 2011

    IAB: 9 FR - 50 CC

    FDA Adverse Event
    Injury ·ARROW INTL., INC.·Product code DSP·June 13, 2008

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·September 23, 2025

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018