BEUDAMED
    11 results · 29ms · Sources: EU EUDAMED, US FDA

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    K-Y PERSONAL LUBRICANT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FORERUNNER AED, US ENGLISH, REFURB

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS (HTST RETURNS)·Product code MKJ·May 31, 2012

    CRP LIPID REAGENT TEST PACK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BIODEX SYSTEM 2 AUTOPROGRAM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·February 11, 2013

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN,NELLCOR PURITAN BENNETT IRELAND·Product code CBK·June 11, 2014

    VIDAS ESTRADIOL II

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code CHP·January 21, 2021

    VIDAS® ESTRADIOL II

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code CHP·September 16, 2021

    Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·July 10, 2024

    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