Yahoo Finance

Medical Device Recalls in the US: In-depth Analysis of Class I and Class II Incidents and Their Impact Featuring Covidien, Draeger Carina, Fresenius Medical Care, and Philips ...

Dublin, Jan. 18, 2024 (GLOBE NEWSWIRE) -- The "US FDA Medical Device Recalls: Trend and Impact Analysis" report has been added to ResearchAndMarkets.com's offering. A comprehensive analysis from a ...
JD Supra

FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)

Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary JANUARY 15 HHS NOTICE RECONSIDERED BY ...
MobiHealthNews

FDA to Opternative: Online eye exams are a Class 2 device

Opternative, a Chicago-based purveyor of online and mobile refractive eye exams, received a warning letter from the FDA last fall. The October 30 warning letter was only recently made public by the ...
JD Supra

Unpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?

It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is ...