A few months later, the broader Olympus Medical Systems Corp. received a separate warning letter related to a Tokyo site that produces accessories for duodenoscopes and bronchoscopes—following ...

Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal ...

Olympus announced recently that it is committed to addressing the concerns of the FDA around its device manufacturing in ...

The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System ...

Olympus is promising swift action to address concerns raised by the Food and Drug Administration (FDA) about some of its ...

The Food and Drug Administration has blocked certain Olympus Medical devices from entering the U.S. because of quality system failings at a site in Japan. FDA officials issued the import alerts ...

The FDA has barred the import of multiple medical devices manufactured by Olympus Medical Systems and its subsidiaries in Japan, citing ongoing violations of federal quality system regulations.

Bronchoscopy has been performed in infants, children, and adolescents by pediatric surgeons and specialists for > 50 years. Until the 1980s, the approach was almost exclusively via the rigid ...

ACIP voted to recommend against anyone — adult, child and pregnant person — receiving a seasonal flu vaccine with the mercury ...

The FDA is notifying healthcare providers about import alerts for certain medical devices manufactured in Japan by Olympus.