BEUDAMED
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    OMYL -ARDE- SPECTACLE FRAME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CPT®

    FDA UDI
    Zimmer, Inc.·00889024164062·

    SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO RESQPOD CIRCULATORY ENHANCER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PORTEX COMBINED SPINAL EPIDURAL ANESTHESIA TRAYS

    FDA Adverse Event
    Injury ·SMITHS MEDICAL, INC.·Product code CAZ·May 19, 2014

    ACCU-CHEK D-TRONPLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 26, 2012

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER-SILICON VALLEY·Product code GEX·September 13, 2010

    in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001), manufactured by Bio-Rad Laboratories Deeside Ltd., Flintshire, UK, distributed by Bio-Rad Laboratories, Hercules, CA. The in2it (I) is for Physician use, the (II) is for prescription home use. The products are medical devices used in affinity chromatography method, intended for the in-vitro quantitative determination of A1c (HbA1C) in capillary blood taken from a finger prick. The test is indicated for monitoring the time averaged blood glucose levels of known diabetics, for professional use as an indicator of overall glycemic control.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code LCP·September 7, 2010

    Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021