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

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    FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2

    FDA 510(k)
    FDA Class 2 ·Immunology

    BD BBL™ Sensi-Disc™ Trimethoprim 5 µg

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902316016·BD BBL™ Sensi-Disc™ Trimethoprim 5 µg

    EVEREST® Spinal System

    FDA UDI
    VB Spine LLC·10888857348004·Provisional Screwdriver (Short) Size 30

    MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DELL U3014 WITH QUBYX PERFECTLUM BUNDLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    DXTEND GLENOSPHERE STD D42MM

    FDA Adverse Event
    Injury ·DEPUY FRANCE·Product code HSD·September 1, 2011

    UNK ENDO GIA SULU

    FDA Adverse Event
    Injury ·NORTH HAVEN-USS·Product code GDW·November 13, 2008

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 17, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

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

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020