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

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    AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·CDS II (SODIUM CHONDROITIN SULFATE)

    PRIMED TRACHEOSTOMY TUBES (MULTIPLE)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BLADEWORKS MICROKERATOME BLADE, MODEL 7061

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    STYLE 68 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·June 6, 2025

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 6, 2012

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NVY·June 4, 2015

    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