BEUDAMED
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    MODIFICATION TO POWERHEART ECD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70609341·Mini Sprint-Brackets Roth .022" 400 Brackets 3 ...

    COLDSTAR INTERNATIONAL INC

    FDA registration
    COLDSTAR INTERNATIONAL INC·3 products·🇺🇸 United States

    MDI SCL-70 TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEXCOM ONE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 13, 2025

    SM304 M-SERIES W/ZOOM

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code INK·April 16, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 14, 2011

    BASE SYSTEM, ILLUMENA, NON-OEM

    FDA Adverse Event
    Other ·LIEBEL-FLARSHEIM CO.·Product code DXT·June 13, 2008

    FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR

    FDA Adverse Event
    Death ·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023

    FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR

    FDA Adverse Event
    Death ·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023

    Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005, 200013, and 200047. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011

    Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011