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

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

    Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·September 6, 2023

    Olympus Airway Mobilescope, Models MAF-GM & MAF-TM.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·September 6, 2023

    Artix MT Thrombectomy Device, REF: 32-102

    FDA Enforcement
    Class II ·Ongoing·Inari Medical - Oak Canyon·May 14, 2025

    One Step K in vitro diagnostic test REF: 81A4

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    One Step 10A in vitro diagnostic test

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    One Step UTI in vitro diagnostic test REF: 3374

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    Uric Acid in vitro diagnostic test REF: 31H0P

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    One Step pH in vitro diagnostic test REF: 31I4P

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    CLARITY II Laser System; Model No. 1110200210.

    FDA Enforcement
    Class II ·Ongoing·Lutronic Corporation·March 18, 2026

    Genesis Push-In Suture Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    Fixone Biocomposite Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    Genesis Knotless Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    Genesis Dual Thread Screw-In Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    Genesis Screw-In Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    AlternatiV+ Max Knotless Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    AlternatiV+ Screw-In Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    Fixone Hybrid Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.

    FDA Enforcement
    Class II ·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025

    Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.

    FDA Enforcement
    Class II ·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025