BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Pneumo Dissector Hook

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LINK Instruments - Sterilization container and trays

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575337057·Sterilization/disinfection container - Endo Mod...

    IMPLANTIUM PROSTHETICS

    FDA 510(k)
    FDA Class 2 ·Dental

    MultiCross Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LCS COMPLETE M/B PAT POR STD+

    FDA Adverse Event
    Injury ·DEPUY IRELAND·Product code NJL·September 19, 2011

    PERSONA FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·November 12, 2014

    12.4CM HEAVY DUTY LONG ATTCH

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 29, 2013

    BD SHARPS COLLECTOR 8QT NEST OPEN TOP NEEDL PORT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·July 7, 2022

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014