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

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    MOI-STIR

    FDA 510(k)
    FDA Unclassified ·Unknown

    SYSLOC MINI V3

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    QT ECG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 4, 2014

    PRECISION XTRA/OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·October 12, 2007

    CAPSUREEPI

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code NVN·October 31, 2012

    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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

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