BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    FUJIFILM Duodenoscope Model

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

    G-Jet® Transgastric-Jejunal Feeding Device

    FDA UDI
    APPLIED MEDICAL TECHNOLOGY, INC.·00842071102616·18FR x 1.7 cm x 45 cm Low Profile Transgastric-...

    G-Jet® Transgastric-Jejunal Feeding Device

    FDA UDI
    APPLIED MEDICAL TECHNOLOGY, INC.·00842071135249·18FR x 1.7 cm x 45 cm Low Profile Transgastric-...

    ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    G-Jet® Transgastric-Jejunal Feeding Device

    FDA UDI
    APPLIED MEDICAL TECHNOLOGY, INC.·00842071135256·18FR x 1.7 cm x 45 cm Low Profile Transgastric-...

    G-Jet® Transgastric-Jejunal Feeding Device

    FDA UDI
    APPLIED MEDICAL TECHNOLOGY, INC.·00842071117351·18FR x 1.7 cm x 45 cm Low Profile Transgastric-...

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·June 6, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    MAMMOTOME CONTROL MODULE WITH SMARTVAC 20/240V

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code KNW·September 30, 2008

    ALINITY C MAGNESIUM

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JGJ·February 16, 2026

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. 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, Cardiac Rhythm Management Division·January 22, 2020