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

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    Air Pressure Therapy System: VU-IPC06

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LIVESURE COCAINE SCREEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ENTERPRISE ELECTROPHYSIOLOGY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    ABBOTT

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code DQX·October 23, 2008

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 12, 2011

    LIVIAN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 8, 2013

    QUICK RELEASE T-HANDLE

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·October 2, 2019

    T-PLIF 10MM TRIAL SPACER 8MM HEIGHT

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWT·October 2, 2019

    Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·October 2, 2013

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020