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

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    Harmony XL Multi-Application Platform

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

    EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS

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

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014

    ADVIA CENTAUR XP

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·June 21, 2013

    PATROL SET

    FDA Adverse Event
    Injury ·ABBOTT NUTRITION·Product code KNT·July 21, 2011

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018