BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    Accusafe Transseptal Guidewire (GTR31180, GTR31230)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    YONGFA

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIPOLAR ENDOCARDIAL LEAD

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS·Product code DTB·September 8, 1997

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    INTERLINK CATHETER EXTENSION SET/MALE LUER

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·November 24, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    5MM FLUTED BALL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 13, 2022

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 12, 2023

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 12, 2023

    Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013