Since the passage of the Medical Device Amendments of 1976, the FDA’s the Center for Devices and Radiologic Health (CDRH) has been responsible for regulating medical devices. These devices have a ...
In a major win for companies hoping to minimize the amount of ethylene oxide (EtO) needed to sterilize medical devices without the risk of 510(k) resubmission, Andersen Sterilizers and its contract ...
The Food and Drug Administration cleared 37 orthopedic- and spine-related devices in September. 1. Clydesdale Spinal System from Medtronic. 2. Longbow Spacer System from Life Spine. 3. Genesys Spine ...
WESTPORT, Conn.--(BUSINESS WIRE)--Connecticut-based medical device innovator Lumendi, LLC today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, ...
Radiology devices on the list include certain collimators, film cassettes, film processors, and digitizers. In the interim period while the FDA proposes and finalizes such down classification and ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
The majority of new medical devices reviewed by FDA enter the market via the 510(k) process. In 2013, FDA cleared approximately 140 510(k)s for every original PMA application approved. For most ...
Company Achieves New Milestone with Over 4,000 Therapeutic Procedures Completed Across the U.S., Europe and Asia, Using DiLumen™ Endoluminal Interventional Platform WESTPORT, Conn.--(BUSINESS ...
In a follow-up to their prior working paper, Brian Miller, William Blanks, and Brian Yagi published a review of 510(k) Third Party Review Program in the Journal of Medical Systems. In their article, ...
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