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FDA Says Purple Wristbands, Bracelets Only for DNR

[ Price : $8.95]

FDA recommends hospitals standardize their use of purple medical device bracelets or wristbands to only signify Do Not Resuscitate...

Tempus PMA for xT-Onco Assay

[ Price : $8.95]

Tempus files a PMA for its broad-panel DNA sequencing xT-Onco assay, an in vitro diagnostic device intended to assist healthcare p...

Utah Cord Bank Hit with Warning Letter

[ Price : $8.95]

A February FDA inspection at Utah Cord Bank (also known as Utah Cell Bank) determines that the firms cell products StemVive and St...

Globus Medical Excelsius Imager Cleared

[ Price : $8.95]

FDA has cleared a Globus Medical 510(k) for the Excelsius3D, an intraoperative three-in-one imaging system.

12 Observations on Imprimis FDA-483

[ Price : $8.95]

FDA releases the FDA-483 with 12 observations from an inspection at the Imprimis drug compounding facility in Lakewood, NJ.

FDA Prioritizing Medical Device Cybersecurity: Post

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MedTech Dive says FDA is seeking legislative authorities to prioritize medical device cybersecurity by imposing new requirements o...

QS Issues Found in Tianjin Bolang Science Tech. Inspection

[ Price : $8.95]

FDA warns Chinas Tianjin Bolang Science Technology Development Co. about Quality System violations in its production of three medi...

BlackBerry QNX Cybersecurity Vulnerabilities

[ Price : $8.95]

FDA says it is working with federal agencies, medical device manufacturers, and the private sector to resolve cybersecurity vulner...

Abbott PMA Approved for Amplatzer Amulet

[ Price : $8.95]

FDA approves an Abbott PMA for the Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation who ar...

Comments Extended for Drug Scheduling Notice

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Federal Register notice: FDA is reopening the comment period for a 7/23 notice on international drug scheduling convention for fiv...