BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    Somfit

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AU BICARBONATE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RAINBOW GT-4A PAIN RELIEF MACHINE

    FDA 510(k)
    FDA Class 2 ·Neurology

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025

    LYNX ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025

    LYNX ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025

    SPACEMAKER BLUNT TIP TROCAR 12MM

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GCJ·November 6, 2014

    ZOOM CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 22, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 17, 2013

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·April 15, 2026

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022