BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    VORTRAN APM-Plus

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·September 3, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·August 20, 2021

    COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·October 21, 2024

    OUTLOOK 400ES LARGE VOLUME INFUSION PUMP

    FDA Adverse Event
    Injury ·B BRAUN MEDICAL INC.·Product code FRN·July 22, 2011

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 10, 2013

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·September 30, 2008

    COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·March 29, 2024

    COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·March 28, 2024

    BD MOLECULAR SWAB COLLECTION KIT

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OUY·October 4, 2022

    COOK CVC SINGLE LUMEN CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·December 28, 2023

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018