BEUDAMED
    83 results · 13ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Open, Classified × Clear all

    Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

    FDA Recall
    Open, Classified ·Staar Surgical AG Haupt Strasse 104 Nidau Switzerland·Product code MTA·April 20, 2026

    stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.

    FDA Recall
    Open, Classified ·Wright Medical Technology, Inc.·Product code KWI·August 3, 2022

    Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A

    FDA Recall
    Open, Classified ·Stryker Sustainability Solutions·Product code IKD·July 2, 2024

    OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

    FDA Recall
    Open, Classified ·SIMPLIVIA HEALTHCARE LTD. NORTH IND. ZONE, (MIGADA PLANT) NORTH IND. ZONE PoBOX·Product code ONB·March 8, 2022

    Puritan Bennett 980 Series Ventilator

    FDA Recall
    Open, Classified ·Medtronic formerly Covidien Michael Collins Road, Mervue Ind. Park Galway Ireland·Product code CBK·March 25, 2022

    (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.

    FDA Recall
    Open, Classified ·LUMENIS, LTD. Yokneam Ind. Park 6, Ha-Kidma Yokne'Am Ilit Israel·Product code GEX·January 23, 2025

    OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.

    FDA Recall
    Open, Classified ·LUMENIS, LTD. Yokneam Ind. Park 6, Ha-Kidma Yokne'Am Ilit Israel·Product code GEX·July 22, 2025

    Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system

    FDA Recall
    Open, Classified ·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025

    Model Number 40KWFXPLUS-710CW, Mobile X-ray system

    FDA Recall
    Open, Classified ·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025

    Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

    FDA Recall
    Open, Classified ·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025

    Model Number 40KWFXPLUS.005, Mobile X-ray system

    FDA Recall
    Open, Classified ·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025

    SM_40HF_B_D_VIR3, Mobile X-ray system

    FDA Recall
    Open, Classified ·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025

    SM_40HF_BDC3, Mobile X-ray system

    FDA Recall
    Open, Classified ·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025

    Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system

    FDA Recall
    Open, Classified ·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025

    Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system

    FDA Recall
    Open, Classified ·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025

    SED URS LP, Mobile X-ray system

    FDA Recall
    Open, Classified ·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025

    Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system

    FDA Recall
    Open, Classified ·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025

    Model Number 40KWFXPLUS.002, Mobile X-ray system

    FDA Recall
    Open, Classified ·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025

    Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation

    FDA Recall
    Open, Classified ·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium·Product code LHN·June 14, 2021

    Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500

    FDA Recall
    Open, Classified ·SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain·Product code IZL·August 12, 2022