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

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    MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6

    FDA 510(k)
    FDA Class 2 ·Microbiology

    S.G 880

    FDA UDI
    Cendres+Métaux SA·97640173080407·S.G 880

    MedStream

    FDA UDI
    MEDICAL SPECIALTIES DISTRIBUTORS, LLC·00842472103038·FLUID AND FILTER CONNECTOR KIT

    MEDICAL SPECIALTIES

    FDA UDI
    Vygon Corporation·08498840006870·FILTER AND FLUID CONNECTOR KIT

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450204245·

    INSET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 8, 2025

    INSET

    FDA Adverse Event
    Injury ·UNOMEDICAL UM-D·Product code FPA·October 8, 2025

    HONIGUM

    FDA 510(k)
    FDA Class 2 ·Dental

    WATER PURIFIER

    FDA 510(k)
    FDA Class 1 ·Dental

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·June 11, 2025

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 5, 2025

    INSET I

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 7, 2025

    TORRENT IRRIGATION TUBING

    FDA Adverse Event
    Malfunction ·UNITED STATES ENDOSCOPY GROUP, INC.·Product code GCJ·March 14, 2013

    ON-Q PAINBUSTER

    FDA Adverse Event
    Injury ·I-FLOW CORPORATION·Product code MEB·March 3, 2011

    QUICKSITE XL LV

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022

    DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 14, 2022

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024