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

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    Filters Regulation: Us FDA ×

    Catalyst CSR Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TEPHAFLEX COMPOSITE MESH

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

    SAPPHIRE PLASMA ARC DENTAL CURING LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    PROLENE HERNIA SYSTEM MESH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·June 21, 2013

    NA

    FDA Adverse Event
    Injury ·NA·Product code FTL·July 21, 2011

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 17, 2014

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019

    HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM

    FDA Adverse Event
    Malfunction ·ACCRIVA DIAGNOSTICS·Product code JPA·December 20, 2018

    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