BEUDAMED
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    DENFIL FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70606371·Sprint II Bracket Roth .018" 100 Brackets

    CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SONOTOME ULTRASONIC ASPIRATOR TIPS

    FDA 510(k)
    FDA Unclassified ·Unknown

    EVOLUT FX VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·July 9, 2025

    LIGASURE IMPACT THORACIC

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·March 27, 2013

    OBTV CLIENT

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code HGM·April 8, 2011

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 13, 2008

    enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

    FDA Enforcement
    Class II ·Terminated·Vital Signs Devices, a GE Healthcare Company·July 18, 2012

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018