BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POLYGRAM NET BIOFEEDBACK APPLICATION

    FDA 510(k)
    FDA Class 2 ·Neurology

    GMK REVISION TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 17, 2024

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 26, 2024

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 26, 2024

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 26, 2024

    VERTE-STACK SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC INC.·Product code NEK·November 6, 2008

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 18, 2011

    TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JEY·July 22, 2013

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    FDA Adverse Event
    Malfunction ·REYNOSE MANUFACTURING·Product code FKX·August 19, 2011

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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