BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Contrast Line

    FDA UDI
    ARGON MEDICAL DEVICES, INC.·00886333207428·Contrast Line 10"(25cm) Male/Female Polyurethan...

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 10, 2013

    MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V

    FDA 510(k)
    FDA Class 2 ·Neurology

    ROMA (HE4 EIA + ARCHITECT CA 125 II)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 23, 2025

    RESOLUTION CLIP DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MND·October 7, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2013

    INTRALASE FS2 LASER

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code HNO·July 29, 2011

    BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·April 28, 2023

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

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