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

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    MIDDLEBROOK & COHN 7H10 AGAR BASE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PRECISION LIQUID DISPENSER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OPTHALMIC ENDOSCOPE

    FDA 510(k)

    EQUINOXE REVERSE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 6, 2024

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 27, 2014

    TR BAND

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DXC·November 15, 2012

    GENESIS XP 8-CHANNEL IPG

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·September 13, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018