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 ...

Please provide your email address to receive an email when new articles are posted on . Less than 20% of recalled CV devices underwent premarket clinical testing, most of which were premarket approval ...

Though Philips recently expanded its ongoing respiratory device recall to include around 5.2 million machines, that list left off a handful of ventilators that weren’t affected by the original issue.