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

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    VARIOLINK

    FDA 510(k)
    FDA Class 2 ·Dental

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515240575·Cheek Ret, sm, 36mm wide swivel bld, 194mm, 7 5/8"

    SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·January 28, 2013

    PORT A CATH II

    FDA Adverse Event
    Injury ·UNK·Product code LJT·December 13, 2010

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·July 14, 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