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

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    CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    Barco

    FDA UDI
    Barco NV·05415334031838·MDSC-8255 LED

    ORTHO DNA PROBE HSV CONFIRMATION TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·February 9, 2013

    ONE STEP COMPLETE ELECTRODE

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MLN·January 3, 2011

    XENFORM

    FDA Adverse Event
    Other ·TEI BIOSCIENCES INC.·Product code FTM·July 11, 2014

    TDXFLX VANCOMYCIN REAGENT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INT'L, LTD·Product code LEH·September 24, 2008

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

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

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024