BEUDAMED
    9 results · 31ms · Sources: EU EUDAMED, US FDA

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    PASCAL SYNTHESIS DELIVERY SYSTEM

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

    HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OLYMPUS ENDOSCOPIC LIGATION DEVICE

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

    LINEAR? 3-4

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 6, 2025

    cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·June 20, 2018

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 29, 2013

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 11, 2011

    PULMONETIC

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC·Product code CBK·July 18, 2008

    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