BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    Qorda QD1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·August 23, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·November 3, 2014

    PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TISSUE·Product code FTL·July 3, 2013

    UNKNOWN FEMORAL HEAD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·March 16, 2017

    CER BIOLOXD OPTION HD 36MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·May 12, 2022

    G7 HI-WALL E1 LINER 36MM H

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PBI·March 16, 2017

    G7 HI-WALL E1 LINER 36MM H

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PBI·March 16, 2017

    M2A-MAGNUM MOD HD SZ 50MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 16, 2015

    M2A-MAGNUM PF CUP 56ODX50ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 16, 2015

    SELEX/MAGNUM MOD HD 40MM +6

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LZO·July 16, 2015

    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