BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    Elecsys TSH assay, cobas e 801 Immunoassay analyzer

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ZAVATION

    FDA UDI
    Zavation LLC·00842166186798·16mm X 26mm 6° Trial

    AVS ANCHOR-C CERVICAL CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 24, 2025

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 11, 2013

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·October 7, 2014

    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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