BEUDAMED
    353 results · 6ms · Sources: EU EUDAMED, US FDA

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

    cobas e801 Immunoassay Analyzer

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·August 17, 2022

    DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)

    FDA Enforcement
    Class II ·Ongoing·ConvaTec, Inc·September 29, 2021

    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

    XERF EFFECTOR 60. Electrosurgical unit.

    FDA Enforcement
    Class II ·Ongoing·Lutronic Corporation·October 22, 2025

    Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.

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