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

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    HEPARIN COATED STAINLESS STEEL/TEFLON

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NOVEOS Conjugate IgE

    FDA UDI
    HYCOR BIOMEDICAL LLC·00816879028836·

    NOVEOS Conjugate IgE

    FDA UDI
    HYCOR BIOMEDICAL LLC·00816879029635·

    BLINK CL LUBRICANT EYE DROPS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·October 16, 2018

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·October 16, 2018

    PANORAMA CENTRAL STATION WITH TELEPACK

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·March 7, 2014

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·November 14, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·September 13, 2010

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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