BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    RICH-MAR HV II SELECT-A-PULSE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NA

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573023042·RESIN-FORMULA 10 7cc 2/PK

    MODIFICATION TO THE GRIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    NA

    FDA UDI
    Zimmer, Inc.·00889024273986·

    NA

    FDA UDI
    Zimmer, Inc.·00889024273337·

    NA

    FDA UDI
    Zimmer, Inc.·00889024273313·

    NA

    FDA UDI
    Zimmer, Inc.·00889024273962·

    NA

    FDA UDI
    Zimmer, Inc.·00889024273320·

    NA

    FDA UDI
    Zimmer, Inc.·00889024273979·

    PREMILENE 4/0 (1.5) 45CM DS19 (M)

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

    CONCERTO CRT-D DR

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

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·August 20, 2010

    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