BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

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    Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACDF STAND ALONE CERVICAL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025

    EUROIMMUN ANTI-ENA POOL ELISA (IGG)

    FDA 510(k)
    FDA Class 2 ·Immunology

    MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR

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

    ACDF STAND ALONE CERVICAL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025

    ACDF STAND ALONE CERVICAL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025

    CUI TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·January 27, 2025

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 27, 2013

    PVC, CLEAR, CONTRAST INJECTION TUBING

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DXJ·July 21, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014

    ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023

    ACDF STAND ALONE CERVICAL

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVE·June 13, 2025

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    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