BEUDAMED
    4 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

    FDA Enforcement
    Class II ·Ongoing·Ithera Medical Gmbh·February 19, 2025

    I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015