BEUDAMED
    207 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (Main) 10885403512667 [323], MD BD Pyxis SupplyStation V9 [317], Security Module [139698-01], BD Knowledge Portal for Medication Technologies [136607-01], STOCKSTN V10.X WRD/WL SCANNERS [132-53-02], PRS STOCKSTN V10.X WRD/WL SCANNERS [132-53-01], STOCKSTN V10.X WIRED SCANNER [132-52-02], PRS STOCKSTN V10.X WIRED SCANNER [132-52-01], BD Pyxis CII Safe ES Desktop PC [1156-00], BD Pyxis SupplyStation Panel PC V11 [1132-00], BD Pyxis SupplyRoller V11 [1127-00], Dell 640 Server [1128-00], BD Pyxis SupplyStation System V11 [1123-00], BD Pyxis CII Safe ES 10885403512605 [1116-00], BD Pyxis Enterprise Server 10885403518348, 10885403520341 [1115-00], BD Pyxis SupplyRoller V10 [1101-00], BD Pyxis CIISafe V9.X SGL IM BIO 10885403512520 [111-221], BD Pyxis CIISafe V7.X DBL INTG MAIN BIO, SOLID DO [111-194], BD Pyxis CIISafe V8.X Desktop PC, Bio [107-245-01], BD Pyxis SupplyStation V10 [347], BD Pyxis CII Safe V9.X DESKTOP PC [107-252-01], BD Pyxis CII Safe V7.X DBL INTG MAIN BIO CLEAR DO [111-191], BD Pyxis CII Safe V7.XSGL INTG MAIN BIO SOLID DO [111-198], BD Pyxis CII SafeV8.XDBL INTG MAIN BIO SOLID DO [111-202-01], BD Pyxis CII SafeV8.XSGL INTG MAIN BIO SOLID DO [111-206-01], BD Pyxis CII Safe V9.X DBL IM BIO SLD DOORS [111-215], BD Pyxis CII Safe V9.X SGL IM BIO CLR DOORS [111-216], BD Pyxis CII Safe V9.X DBL IM BIO CLR DOORS [111-219], Supply itParActive RF V11 (Supply Kanban) [138566-01]

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·July 2, 2025

    BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·April 19, 2023

    BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·April 19, 2023

    Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

    FDA Enforcement
    Class II ·Ongoing·SCIENCE & BIO MATERIALS·May 14, 2025

    Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories·April 3, 2024

    PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.

    FDA Enforcement
    Class II ·Ongoing·Nihon Kohden America Inc·February 3, 2021

    Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Perfusion Systems·October 13, 2021

    Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One North America, Inc.·November 5, 2025

    BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended to securely store and dispense medications and supplies to a qualified and authorized user in a clinical setting.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·March 5, 2025

    HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400

    FDA Enforcement
    Class II ·Ongoing·Hamilton Co·March 10, 2021

    Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000.

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·September 27, 2023

    Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0206-530-000

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·September 27, 2023

    Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-703-000

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·September 27, 2023

    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-564-000

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·September 27, 2023

    Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·September 27, 2023