BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    EEA Circular Stapler with Tri-Staple Technology

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

    ZIP'R4/ ZIP'R4 XTRA SCOOTER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ALAMO C

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 3, 2025

    ORS-320 SLUSH WARMER DISC DRAPE

    FDA Adverse Event
    Malfunction ·MICROTEK DOMINICANA, S.A.·Product code LHC·May 1, 2018

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·June 5, 2013

    TERUMO TCM II COOLING AND HEATING SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·October 9, 2014

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 17, 2011

    Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014