BEUDAMED
    25 results · 14ms · 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

    Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code CFN·May 27, 2024

    Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code CFN·July 12, 2023

    UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code JMO·June 26, 2025

    3mensio Workstation (Vascular Fenestrated) software

    FDA Recall
    Open, Classified ·PIE Medical Imaging B.V. Demertdwarsstraat 8A01 Maastricht Netherlands·Product code LLZ·July 14, 2025

    IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439

    FDA Recall
    Open, Classified ·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024

    IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441

    FDA Recall
    Open, Classified ·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024

    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025

    Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code HIH·June 18, 2025

    TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808

    FDA Recall
    Open, Classified ·Covidien Llc·Product code HIH·June 7, 2022

    VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025

    Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code HIH·September 25, 2023

    OES 4000 Hysteroscope, Model/Catalog Number: A4674A

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code HIH·April 18, 2024

    IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434

    FDA Recall
    Open, Classified ·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024

    NexxZr T Multi A3.5 W98-16mm, REF: 745451

    FDA Recall
    Open, Classified ·Sagemax Bioceramics, Inc.·Product code EIH·December 11, 2025

    Visera Hysterovideoscope Olympus HYF Type V

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code HIH·July 20, 2023

    Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code HIH·November 11, 2025

    IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437

    FDA Recall
    Open, Classified ·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024

    IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443

    FDA Recall
    Open, Classified ·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024

    IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438

    FDA Recall
    Open, Classified ·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024

    UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO

    FDA Recall
    Open, Classified ·Scholly Fiberoptic Gmbh Robert-Bosch-Str. 1-3 Denzlingen Germany·Product code HIH·June 23, 2023