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

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    PREVENT I

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SafeT T-Piece Resuscitator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SYNGO VOLUME PERFUSION-CT BODY

    FDA 510(k)
    FDA Class 2 ·Radiology

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC·Product code DQO·August 5, 2015

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 21, 2013

    ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

    FDA Adverse Event
    Malfunction ·DYNAMIC CONTROLS·Product code CCL·August 1, 2014

    IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter --- Manufactured for: B. Braun Interventional Systems Inc., 824 Twelfth Avenue Bethlehem, PA18018 --- Manufactured by: NuMED, Inc. 2880 Main Street, Hopkinton, NY 12965 --- The Impact catheter is packaged in a straight sheath and then heat sealed in two Tyvek pouches. The inner pouch is the one that is deteriorating when exposed to the sunlight. The outer pouch retains its seal so the sterility is not compromised. --- 510 K931009 - Device Listing #D003206 and 510 K983373 - Device Listing # D003212, Class II device.

    FDA Recall
    Terminated ·Numed Inc·Product code LIT·September 23, 2009