BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    BAUSCH & LOMB GR-3 REFRACTOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Endodontic Hand Instruments

    FDA UDI
    TULSA DENTAL PRODUCTS LLC·D71668625211·Senseus Flexofile Size 025 21mm

    OXALATE URINE CONTROLS (NORMAL AND ELEVATED)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CK-MB(IMMUNOLOGICAL)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MAXIMO II CRT-D

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014

    INSYNC III

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·October 8, 2010

    ENSEAL SUPER JAW

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·December 10, 2012

    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