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

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    maiLink

    FDA 510(k)
    FDA Class 2 ·Radiology

    iSmile

    FDA UDI
    Ismile Dental Products, Inc.·00816419021600·Headrest Cover Tissue/Poly 13" x 10" Lavender

    LOQTEQ®

    FDA UDI
    aap Implantate AG·04042409403514·LOQTEQ® VA Cortical Screw 2.5, T8, L 8 Titanium

    INVISION Total Ankle Revision System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    E-Z-EM ENDOSCOPIC CO2 REGULATOR

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

    ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC·Product code OCW·December 3, 2008

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011

    PENUMBRA NON-STERILE PUMP MAX CANISTER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code JCX·July 29, 2013

    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 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

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021