BEUDAMED
    40 results · 13ms · Sources: EU EUDAMED, US FDA

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    LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code LWS·February 2, 2023

    KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing

    FDA Recall
    Open, Classified ·Microbiologics Inc·Product code JTR·August 14, 2023

    Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform

    FDA Recall
    Open, Classified ·Fenwal Inc·Product code LKN·February 14, 2023

    Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.

    FDA Recall
    Open, Classified ·Wilson-Cook Medical Inc.·Product code FFL·June 22, 2023

    Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform

    FDA Recall
    Open, Classified ·Fenwal Inc·Product code LKN·February 14, 2023

    Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.

    FDA Recall
    Open, Classified ·Wilson-Cook Medical Inc.·Product code FFL·June 22, 2023

    Perifix / Epidural anesthesia set, medicated

    FDA Recall
    Open, Classified ·B. Braun Medical, Inc.·Product code OGE·July 31, 2023

    Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·September 14, 2023

    Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·September 14, 2023

    L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile

    FDA Recall
    Open, Classified ·Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany·Product code HCH·July 14, 2023

    L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile

    FDA Recall
    Open, Classified ·Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany·Product code HCH·July 14, 2023

    Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·September 14, 2023

    LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17

    FDA Recall
    Open, Classified ·Cardiac Assist, Inc·Product code KFM·June 30, 2023

    remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora

    FDA Recall
    Open, Classified ·Remel, Inc·Product code JSD·August 14, 2023

    Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Reconstitution Collars.

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code PAB·September 14, 2023

    Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754

    FDA Recall
    Open, Classified ·Steris Corporation·Product code HBM·December 12, 2023

    FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QBH·December 14, 2023

    Access Thyroglobulin Calibrators

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code MSW·July 6, 2023

    FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QDS·December 14, 2023

    Dual Articulating Headrest, Velcro P/N P141210813, REF BF753

    FDA Recall
    Open, Classified ·Steris Corporation·Product code HBM·December 12, 2023