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

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    ARIX Hand System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY

    FDA 510(k)
    FDA Unclassified ·Unknown

    COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID

    FDA 510(k)
    FDA Unclassified ·Unknown

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·July 7, 2025

    PLUM A+ DRIVER ED 2

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·July 8, 2011

    ATTAIN STARFIX

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·October 10, 2014

    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