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

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    FERTILMARQ TEST KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    AMSafe(R) Pre-Filled Normal Saline Flush Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CLEAR BRAVO

    FDA 510(k)
    FDA Class 2 ·Dental

    SUPERTORQUE 5F MARKER BAND FLUSH CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code DQO·February 28, 2013

    PFC SIGMA CRVD INSERT SZ5 10MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·January 31, 2011

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 23MM

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code NPT·August 6, 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