BEUDAMED
    12 results · 28ms · 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.

    Permatage Flowable, Settable Hemostatic Bone Paste

    FDA 510(k)
    FDA Unclassified ·Unknown

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·June 25, 2025

    E-CUBE 11

    FDA 510(k)
    FDA Class 2 ·Radiology

    AEQUALIS REVERSED PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CDS/R/4K DILUENT/SHEATH, 20L

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIV/CELLDYN·Product code GKL·April 12, 2007

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 17, 2025

    CD SAPPHIRE, CD 4000 SYSTEMS DILUENT/SHEATH

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIV/CELLDYN·Product code GKL·December 8, 2006

    CELL-DYN DILUENT/SHEATH

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007

    7600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·August 19, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 19, 2014

    HS III PROXIMAL SEAL

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR·Product code DXC·July 30, 2013

    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