BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Gen. Acces/ Instr. Tip Guard

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110850·TIP GUARDS VENTED WHITE PACK OF 100

    SURGISEAL TWIST TOPICAL SKIN ADHESIVE

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

    CRANIAL HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    TI STERNAL LOCKING DOUBLE-T PLATE/14 HOLES

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·November 30, 2018

    EXTENSION SET 30IN

    FDA Adverse Event
    Malfunction ·HOSPIRA INC.·Product code FPA·June 3, 2009

    APM/AIM PUMP SET W/C

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·September 28, 2010

    SYMBIQ DUAL CHANNEL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·January 18, 2013

    SYNCHROMED

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·December 22, 2010

    LIGAMAX CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 17, 2014

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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