BEUDAMED
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    Filters Regulation: Us FDA ×

    ExactechGPS System

    FDA 510(k)
    FDA Class 2 ·Neurology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198406·AK3 PS Insert Trial Size 6, 18mm

    BILI-MIRROR MODEL BLM-1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INDIGO SYSTEM ASPIRATION CATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code DXE·August 11, 2020

    LANDMARX ELEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 13, 2011

    INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code GEI·June 21, 2013

    PROXIMAL HUMERAL PLATE, EXTRA LONG, R.

    FDA Adverse Event
    Malfunction ·ACUMED LLC·Product code HRS·October 22, 2014

    HANDLE BATTERY POWERED DRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·June 9, 2025

    Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026