BEUDAMED
    17 results · 34ms · Sources: EU EUDAMED, US FDA

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    GRAFT HARVESTING SAWBLADES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MINI TIGHTROPE FT REPAIR KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code LMF·November 28, 2018

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code LMF·November 28, 2018

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX)

    FDA Adverse Event
    Malfunction ·ANGIOSCORE, INC.·Product code NWX·February 15, 2013

    COAGUCHEK® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·January 27, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 31, 2014

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code LMF·November 28, 2018

    UNK - CONSTRUCTS: VEPTR

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code MDI·February 25, 2021

    HANDLE MINI-QUICK-COUPL

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWX·April 16, 2020

    UNKNOWN KNEE CONSTRUCT SIGMA

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·August 29, 2024

    PIPELINE

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·September 18, 2023

    PIPELINE

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·September 18, 2023

    REMINGTON MEDICAL DISPOSABLE PACING CABLE

    FDA Adverse Event
    Malfunction ·REMINGTON MEDICAL·Product code DSA·September 13, 2002

    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