BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER

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

    TelePatch Cardiac Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEURO II-SE, MODELS OR-MB-DR AND OR-DR

    FDA 510(k)
    FDA Class 2 ·Radiology

    LOGIC TIBIA PS MOD INSRT SZ 3 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 23, 2024

    INCHECK PATIENT ASSISTANT

    FDA Adverse Event
    Injury ·PLEXUS MANUFACTURING SDN. BHD·Product code NVZ·June 10, 2014

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·October 31, 2012

    ENTRUST VR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012