BEUDAMED
    11 results · 37ms · Sources: EU EUDAMED, US FDA

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    INSTA-BOND

    FDA 510(k)
    FDA Class 2 ·Dental

    Needle Holder

    FDA UDI
    KOROS U.S.A., INC.·10840199534194·Needle Holder Micro Tungsten Grip Curved Stainl...

    ADVANTA SST GRAFT (<6MM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CorPath GRX System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    L.C. 5000/CE NITROGL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·July 27, 2009

    NITRO I.V. DC INF. SET W/LB TBG

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 16, 2011

    L.C. 5000/CE NITROGLYCERIN PUM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 22, 2012

    NOVOSYN VIOLET 2 (5) 90CM HR48 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL S.A.·Product code GAM·April 16, 2014

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 29, 2015

    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