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

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    ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    REVELATION DIAMOND

    FDA UDI
    Ss White Burs, Inc.·D6909142252·REVELATION DIAMOND KS5-031SC - 5 PACK

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122247·KWire .054x9" (1.4x225mm)

    Gen. Acces/ Instr. Tip Guard

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110867·TIP GUARDS VENTED BLUE PACK OF 100

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450841211·

    BREATHTEK - UBIT UBT FOR H. PYLORI

    FDA 510(k)
    FDA Class 1 ·Microbiology

    KWIKMIX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HUDSON AQUAPAK 301 SW,340 ML,INTL

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTT·September 29, 2015

    HUDSON AQUAPAK 301 SW,340 ML,INTL

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTT·September 29, 2015

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 14, 2013

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·November 18, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 3, 2014

    HUDSON AQUAPAK 301 SW,340 ML,INTL

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTT·September 29, 2015

    HUDSON AQUAPAK 301 SW,340 ML,INTL

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTT·September 29, 2015

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012