BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    ESENSOR RESPIRATORY VIRAL PANEL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750004843·MED QUEST MASK/HG GRN22OD SWL

    BIO-MODULAR SHOULDER SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304433601·

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642105094·PS2 Screw 7.5mm x 30mm

    GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    CAPSTONE R SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 12, 2019

    ON-Q PAINBUSTER: SILVERSOAKER 2.5IN, 100ML, 2ML/HR

    FDA Adverse Event
    Injury ·I-FLOW, LLC·Product code MEB·May 10, 2013

    HEARTSTREAM FR2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 17, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·June 2, 2011

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021