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

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    ERIE-NEB

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05

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

    iSage Rx (iSage Rx Basal Insulin Titration)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TIBIAL INSERT MB SZ 1 LT 6MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSN·March 12, 2026

    AMISTEM H FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·November 27, 2012

    SIGMA 100 VVI

    FDA Adverse Event
    Injury ·MEDTRONIC OF CANADA LTD.·Product code DXY·October 8, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 13, 2014

    DRAINAGE STENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FGE·October 24, 2017

    SPRINT QUATTRO SECURE S MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·April 3, 2023

    CAPSURE Z NOVUS LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·April 3, 2023

    ATTAIN STARFIX LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code OJX·April 3, 2023

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    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

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012