BEUDAMED
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    GORE-TEX TUNNELER

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    IRIS

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975000583·Iris 5% NAF VARNISH - White Raspberry (30)

    NABI CRP-Q.S. TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    SPOTTEST ACRIDINE ORANGE STAIN

    FDA 510(k)
    FDA Class 1 ·Microbiology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 26, 2012

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·September 23, 2010

    PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles. The function of the Wick is to draw urine away from the body through the Wick to a storage container away from the body through a PVC tube via a continuous, low pressure vacuum pump (PureWick DryDoc) or to a hospital wall vacuum. There is never a reversal of flow direction or static state of fluid between the device and the patient. Also, the dry natural rubber component is double wrapped with 75D polyester and it is not stretched in its application to expose bare rubber to a user. The Wick does not enter the vagina (Figure 1).

    FDA Recall
    Terminated ·Purewick Corporation·Product code NNW·February 24, 2016

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015