BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    OLYMPUS SD SERIES SNARES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    KINETIC ALKALINE PHOSPHATASE DETERMINATION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HUMAN IGG SUBCLASS RID KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    PATHROMTIN SL

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code GFO·August 11, 2017

    PATHROMTIN SL

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code GFO·August 11, 2017

    PATHROMTIN SL (RILIBAK)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code GFO·January 4, 2023

    FLEXIMA¿ BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FGE·February 11, 2013

    QUICKFLEX MICRO LV LEAD

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

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 24, 2014

    NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·July 10, 2023

    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