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

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    Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10

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

    AGC V2 TOTAL KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·05019279383771·

    LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036055998·

    Endo-Model Modular Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575316731·Hinge Knee Joint Prosthesis,Tibial component

    Endo-Model Modular Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575316748·Hinge Knee Joint Prosthesis,Tibial component

    Endo-Model Modular Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575316755·Hinge Knee Joint Prosthesis,Tibial component

    Endo-Model Modular Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575316762·Hinge Knee Joint Prosthesis,Tibial component

    MREYE EMBOLIZATION COIL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·May 22, 2024

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 3, 2026

    Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·July 24, 2024

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·July 7, 2011

    ENRHYTHM

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 8, 2013

    CD HORIZON AGILE SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC INC.·Product code NQP·September 4, 2008

    MERGE HEMO

    FDA Adverse Event
    Malfunction ·MERGE HEALTHCARE·Product code DQK·September 24, 2024

    ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·February 23, 2017

    MERGE HEMO

    FDA Adverse Event
    Malfunction ·MERGE HEALTHCARE·Product code DQK·September 24, 2024

    MERGE HEMO

    FDA Adverse Event
    Malfunction ·MERGE HEALTHCARE·Product code DQK·September 25, 2024

    MERGE HEMO

    FDA Adverse Event
    Malfunction ·MERGE HEALTHCARE·Product code DQK·September 24, 2024