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

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    FEP-RINGED GORE-TEX@ VASCULAR GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTEGRA PROXIMAL HUMERAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·May 20, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 6, 2012

    ECHELON*FLEX60 LONG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 31, 2010

    UNKNOWN ENDO GIA SULU

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·March 12, 2010

    UNKNOWN ENDO GIA SULU

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·March 12, 2010

    UNKNOWN ENDO GIA SULU

    FDA Adverse Event
    Injury ·UNITES STATES SURGICAL·Product code GDW·March 12, 2010

    UNKNOWN ENDO GIA SULU

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHCARE GROUP·Product code GDW·March 12, 2010

    UNKNOWN ENDO GIA SULU

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHCARE GROUP·Product code GDW·March 12, 2010

    UNK - IMPLANT

    FDA Adverse Event
    Injury ·DEPUY MITEK LLC US·Product code HWC·November 30, 2021

    UNKNOWN ENDO GIA SULU

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHCARE GROUP·Product code GDW·March 12, 2010

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; 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;

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

    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