BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

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    LifeBubble

    FDA UDI
    NOVONATE INC·10850002447245·LifeBubble Kit, Small (20/case)

    LifeBubble

    FDA UDI
    NOVONATE INC·10850002447221·Adhesive Pack, Small (20/case)

    LifeBubble

    FDA UDI
    NOVONATE INC·10850002447085·LifeBubble, Large (20/case)

    LifeBubble

    FDA UDI
    NOVONATE INC·00850002447316·LifeBubble Evaluation Kit (30/case)

    LifeBubble

    FDA UDI
    NOVONATE INC·00850002447972·LifeBubble Buddy, Catheter Insertion Site Acces...

    LifeBubble

    FDA UDI
    NOVONATE INC·10850002447269·LifeBubble Buddy (40/case)

    LifeBubble

    FDA UDI
    NOVONATE INC·00850002447101·LifeBubble, Small (20/Case)

    LifeBubble

    FDA UDI
    NOVONATE INC·00850002447934·Adhesive Pack (20/case)

    LifeBubble

    FDA UDI
    NOVONATE INC·00850002447927·LifeBubble Kit, Umbilical Catheter Securement S...

    LifeBubble

    FDA UDI
    NOVONATE INC·10850002447207·LifeBubble, Small (20/case)

    LifeBubble

    FDA UDI
    NOVONATE INC·10850002447160·Adhesive Pack, Large (20/case)

    LifeBubble

    FDA UDI
    NOVONATE INC·00850002447910·Umbilical Catheter Securement System (20/case)

    LifeBubble

    FDA UDI
    NOVONATE INC·00850002447118·Adhesive Pack, Small (20/Case)

    LifeBubble

    FDA UDI
    NOVONATE INC·10850002447184·LifeBubble Kit, Large (20/case)

    LifeBubble

    FDA UDI
    NOVONATE INC·00850002447095·LifeBubble Kit, Small (20/Case)

    Endeavor Resolute Zotarolimus-Eluting Coronary Stent System with Rapid Exchange Delivery System, UPN 00613994400505, model #IDERES25024X. Manufacturer: Medtronic, Inc. Minneapolis, MN. Manufactured in: Medtronic Ireland, Galway, Ireland. Product is packaged inside a sterile, inner pouch, labeled in part "Use immediately". Inner pouch is supposed to be within a foil pouch containing desiccant, and moisture absorber. Foil pouch label reads in part "RX Endeavor Resolute Zotarolimus-Eluting Coronary Stent System...2.5 mm X 24 mm...REF IDERES25024X...Contents: One (1) Endeavor Resolute zotarolimus-eluting stent mounted on a rapid exchange stent delivery system...Guide Catheter/Minimum Inner Diameter >=5F/0.056" (1.42 mm)...Maximum Guidewire Diameter 0.014" (0.36 mm)...Maximum Stent I.D. 3.00 mm (0.12"...Nominal Pressure 9 atm (912 kPa)...Rated Burst Pressure 15 atm (1520 kPa)...MR Conditional...Sterilized using ethylene oxide Consult instructions for use...Manufacturer: Medtronic, Inc. 710 Medtronic Pkwy NE Minneapolis, MN 55432 USA...Manufactured In: Medtronic Ireland Parkmore Business Park West, Galway, Ireland Tel:+353-91-708000 Fax:+353-91-757524 Investigational Devices / Returned Goods: Tel: (800) 556-4247 / Fax: (877) 518-2469...BioLinx Medtronic Polymer System". Foil pouch contents and Instructions for Use are placed within an outer box, which is labeled identically to the foil pouch. The Endeavor Resolute System is intended for use in patients with ischemic heart disease due to stenotic lesions contained within de novo native coronary arteries with reference vessel diameters between 2.25mm and 4.2mm and lesion lengths S 27mm that are amenable to percutaneous treatment with a stent.

    FDA Recall
    Terminated ·Medtronic Vascular Galway Limited Parkmore Business Park West Galway Ireland·Product code NIQ·August 6, 2009