BEUDAMED
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    LIFEPAK 500 BIPHASIC

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    XIA 3 SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Digital Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ARCHITECT HIV AG/AB COMBO

    FDA Adverse Event
    Injury ·ABBOTT GERMANY·Product code MZF·February 28, 2013

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTL LTD·Product code KWA·January 31, 2011

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·July 7, 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