BEUDAMED
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    D-STAT RADIAL HEMOSTATIC BAND

    FDA 510(k)
    FDA Unclassified ·Unknown

    MedGyn Pessary Dish w/o support # 4

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803050133·Dish Pessary is used to treat uterine prolapse.

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450141489·

    MENICON Z

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VERSALUX

    FDA 510(k)
    FDA Class 2 ·Dental

    2124215-2013-03424

    FDA Adverse Event
    Malfunction ·GUIDANT PUERTO RICO BV·Product code NVN·April 10, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 30, 2014

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 1, 2011

    Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 760 ML W/Adaptor, Product No. 037-28C; Aquapak 728 SW, 760 ML W/28 Adaptor, French, Product No. 037-02F; Aquapak 733 SW, 760 ML W/033 Adaptor, Product No. 037-33; Aquapak 735 HNS, 760 ML W/028 Adaptor, Product No. 037-35; Aquapak 739 FNS, 760 ML W/028 Adaptor, Product No. 037-39; Aquapak 0.9% NACL, 760 ML W/Adaptor, Product No. 037-39C; Aquapak 770 HNS, 760 ML W/033 Adaptor, Product No. 037-70; Aquapak 1028 SW, 1070 ML W/028 Adaptor, Product No. 041-28; Aquapak SW/EAU Sterile, 1070 ML W/Adaptor, Product No. 041-28C; Aquapak 1033 SW, 1070 ML W/033 Adaptor; Product No. 041-33; Aquapak 1035 HNS, 1070 ML W/028 Adaptor, Product Code 041-35; Aquapak 428 SW, 440 ML W/028 Adaptor, Product No. 044-28; Aquapak SW/EAU Sterile, 440 MLW/Adaptor, Product No. 044-28C; Aquapak 428 SW, 440 ML W/028 Adaptor, French, Product No. 044-28F; Aquapak 433 SW, 440 ML W/033 Adaptor, Product No. 044-33; Aquapak 435 HNS, 440 ML W/028 Adaptor, Product No. 044-35; Aquapak 470 HNS, 440 ML W/033 Adaptor, Product No. 044-70. Used in anesthesiology.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 10, 2014

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018