BEUDAMED
    11 results · 19ms · 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.
    Filters Regulation: Us FDA ×

    OverStitch NXT Endoscopic Suturing System

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

    SIMPLY ICONIC SBM IMP 4.2X3.0 PLAT 13MML

    FDA Adverse Event
    Injury ·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·February 6, 2025

    SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    XTRA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014

    ADVANTAGE SERIES 29

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

    EON

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·July 18, 2019

    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