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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES

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

    P.F.C.

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295215981·P.F.C. MODULAR PLUS FULL WEDGE TRIAL SZ 5 15 DEG

    Tuohy NRFit

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PEPER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·March 24, 2026

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 7, 2010

    OLYMPUS EVIS EXERA II GI VIDEOSCOPE

    FDA Adverse Event
    Other ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDS·November 30, 2012

    EQUINOXE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·March 24, 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