BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RTE SNAPCONE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FHW·July 11, 2023

    PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    GOODNET

    FDA 510(k)
    FDA Class 2 ·Radiology

    REAR TIP EXTENDER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code N/A·December 30, 2025

    RTE SNAPCONE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FHW·February 17, 2021

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    FDA Adverse Event
    C.T.M. HOMECARE PRODUCT, INC·Product code INI·May 2, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 19, 2011

    INDURA CATHETER

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·August 1, 2008

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018