BEUDAMED
    9 results · 37ms · Sources: EU EUDAMED, US FDA

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    SCANLAN STERNUM NEEDLE-SUTURE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    NON-VENTED HIGH-VOLUME INLET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - ROUND LAKE·Product code LHI·July 24, 2019

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 12, 2014

    ENDURANT II STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·October 23, 2012

    MAGIC 3TM FEMALE INTERMITTENT CATHETER

    FDA Adverse Event
    Malfunction ·ROCHESTER MEDICAL CORP.·Product code KOD·May 27, 2015

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022