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

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    DUMEX PAK-ITS WOVEN RIBBON PACKING

    FDA 510(k)
    FDA Unclassified ·Unknown

    MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Straumann BLX Surgical Cassette

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45

    FDA 510(k)
    FDA Class 2 ·Radiology

    FEMORAL STEM 12/14 NECK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 26, 2022

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·February 27, 2013

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 7, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·July 24, 2014

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·May 10, 2019

    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