BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    Etgar Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319

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

    VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONTINU-FLO

    FDA Adverse Event
    Malfunction ·BAXTER·Product code FPA·July 11, 2011

    PLUM XLM W/DATAPORT

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 3, 2013

    PKS LYONS DISSECTING FORCEPS W/ATTACHED CORD

    FDA Adverse Event
    Malfunction ·GYRUS MEDICAL, INC.·Product code GEI·September 10, 2008

    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