BEUDAMED
    7 results · 25ms · 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.

    CHARTR ENG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PALINDROME SAPPHIRE 23/40KT VT

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MSD·April 14, 2014

    RSP SHOULDER

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code KWS·January 22, 2013

    LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM

    FDA Adverse Event
    Injury ·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code NIP·December 10, 2010

    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