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

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    Filters Classification: Class Ii ×

    Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010

    FDA Enforcement
    Class II ·Ongoing·Healthmark Industries Co., Inc.·June 11, 2025

    SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,

    FDA Enforcement
    Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023

    Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V

    FDA Enforcement
    Class II ·Terminated·Sonesta Medical Ab·May 10, 2017

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    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