BEUDAMED
    9 results · 49ms · Sources: EU EUDAMED, US FDA

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    ACUMEN CORONARY SINUS VISUALIZATION SYSTEM

    FDA Adverse Event
    Malfunction ·ACUMEN MEDICAL, INC.·Product code DQY·June 11, 2005

    INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM

    FDA Adverse Event
    Malfunction ·ACUMEN MEDICAL, INC.·Product code DQY·December 14, 2006

    ACUMEN BLUSHEATH DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·ACUMEN MEDICAL, INC.·Product code DYB·December 27, 2007

    ACUMEN LEAD DELIVERY SHEATH

    FDA Adverse Event
    Malfunction ·ACUMEN MEDICAL, INC.·Product code DYB·April 20, 2006

    ACUMEN BLUESHEATH DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·ACUMEN MEDICAL, INC.·Product code DYB·September 19, 2007

    CMC Medical Devices & Drugs SL

    Authorized representative
    🇪🇸 Spain·698 Manufacturers·11260 Devices

    Kingsmead Service B.V.

    Authorized representative
    🇳🇱 Netherlands·243 Manufacturers·2698 Devices

    Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device, C.R. Bard, Inc., Covington, GA 30014. The catheter is an open whistle tip with two eyes on the same side. It is made of red latex for added catheter stiffness and radiopacity, with a Lubricath hydrophilic coating. This product has 3 lumens; a lumen for drainage, a lumen for inflation of the bladder balloon, and a lumen for inflation of the prostatic balloon.

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code MJC·August 29, 2002

    NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure (see labelling). The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guide wire to position the catheter. Radiopaque balloon marker(s) enable accurate placement. Shaft markers for brachial and femoral techniques are in place.

    FDA Recall
    Terminated ·Medtronic Vascular, Inc.·Product code LOX·September 16, 2013