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

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    Unified Arrhythmia Diagnostic System PocketECG IV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Orthos

    FDA UDI
    ORMCO CORPORATION·00889989030372·ORTHOS CM NITI ARCH18 DIA LOSM PK10

    ONE TOUCH BASIC ORIGINAL

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·December 21, 2001

    ONE TOUCH BASIC

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·December 21, 2001

    SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OMNIFIX®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FMF·March 6, 2026

    IN TOUCH ZX

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL QUEBEC LP·Product code FNL·October 6, 2008

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·July 22, 2011

    HUDSON SPIRAL-FLEX ENDOTRACHEAL TUBE, 7.5MM

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTR·June 21, 2013

    Quanta System Sterile Optical Laser Fiber, reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026