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

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    EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014607634·STERIS-AMSCO 1080, 2080 3" DELUXE

    Batrik Brush/Blue/BD 8+10mm/BL 50mm

    FDA UDI
    Batrik Medical Manufacturing Inc·00690521008007·Brush/Blue/BD 8+10mm/BL 50mm/OL 80cm - Asymetri...

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023864·BAYONETTED ANGLED RING CURETTE

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221024879·Unitek(TM) MIA Mobile Interarch System Curved L...

    Azur Pure Helical

    FDA UDI
    Microvention, Inc.·00810170018244·Azur

    QUALITROL LIPID CONTROL, LEVELS 1 AND 2

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EPIDURAL CATHETERIZATION SET

    FDA Adverse Event
    Malfunction ·Product code CAZ·October 26, 2020

    MAQUET SAS

    FDA Adverse Event
    Injury ·MAQUET S.A.S·Product code FTD·April 9, 2013

    LIFECARE

    FDA Adverse Event
    Malfunction ·HOSPIRA·Product code MEA·September 5, 2014

    AU681-02E CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JJE·May 6, 2011

    EPIDURAL CATHETERIZATION SET

    FDA Adverse Event
    Malfunction ·Product code CAZ·December 17, 2020

    EPIDURAL CATHETERIZATION SET

    FDA Adverse Event
    Malfunction ·Product code CAZ·October 19, 2020

    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