BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO HIGHGATE CURVED ROD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NA

    FDA Adverse Event
    Malfunction ·STERILMED, INC.·Product code NUJ·May 15, 2013

    SIGMA 100 VVI

    FDA Adverse Event
    Injury ·MEDTRONIC OF CANADA LTD.·Product code DXY·June 14, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 20, 2008

    BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 18, 2021

    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·August 24, 2016