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

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    GTI-PF4 ELISA

    FDA 510(k)
    FDA Class 2 ·Hematology

    MODELS 4000/4900/6000/8000/8900 ND:YAG & 1700 CO2

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON INC·Product code OTP·February 28, 2013

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·July 7, 2014

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 4, 2011

    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