BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    STA-SET MODEL 250 I.V. FLOW REGULATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BONE PLUGGING TOOL

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    VENOUS RESERVOIR VRS-XXX SERIES; HOLDER VRS-HXX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 10, 2014

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·October 11, 2010

    CAPSURE

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·December 10, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055;

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021