Philips Medical Systems - FDA 510(k) Cleared Devices

Philips Medical Systems is a Dutch multinational health technology company headquartered in Amsterdam with U.S. operations based in Seattle. The company evolved from a consumer electronics conglomerate founded in 1891 to a healthcare-focused organization.

Philips Medical Systems has received 105 FDA 510(k) clearances from 107 total submissions between 2002 and 2021. The company's regulatory focus centered on Cardiovascular devices, which represented 79% of all submissions. This historical record reflects the company's significant presence in diagnostic ultrasound systems and patient monitoring technologies.

The company's cleared device portfolio included diagnostic ultrasound systems, electrocardiographs, patient information centers, and vital signs monitors. These products served clinical settings requiring advanced diagnostic and monitoring capabilities.

Explore the complete regulatory history by reviewing individual device names, product codes, and clearance dates in the database.