BEUDAMED
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    FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970585·anteriors; shade A2 light; mould BM

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809665586018·MIS Fenestrated Screw, Ø10.5 x 85mm, Ø6.0mm Rod

    ACCU-CHEK PERFORMA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Skylife

    FDA 510(k)
    FDA Class 2 ·General Hospital

    1000 ML TPN BAG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·December 9, 2020

    VENTED MICRO VOL.INLET, N/S

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022

    250 ML TPN BAG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 21, 2021

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·June 2, 2014

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·February 20, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·January 25, 2011

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    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