BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

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    Pangea Utility Plating System, Pangea Platform

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HWC·January 23, 2026

    MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR

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

    GE OEC 2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008

    MICRO SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·July 25, 2011

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·July 17, 2013

    UNSPECIFIED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 15, 2025

    BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 23, 2024

    CARTO 3

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·September 16, 2024

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024

    CARTO 3

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 28, 2025

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024

    CARTO 3

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 15, 2025

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025