BEUDAMED
    7 results · 21ms · 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.

    AS 123 PROSTHETIC INSTRUMENTATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CD8 CYTOSPHERES KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACCU-CHEK ® FASTCLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·February 15, 2013

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·January 19, 2011

    RESTAYLANE L, RESTYLANE LIDOCAINE

    FDA Adverse Event
    Injury ·Product code LMH·July 14, 2014

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021