Carl Zeiss Meditec, AG - FDA 510(k) Cleared Devices

Carl Zeiss Meditec, AG, is a global medical device manufacturer specializing in innovative solutions for ophthalmology and microsurgery. The company operates with a manufacturing facility in Dublin, US, and delivers diagnostic and surgical instruments to healthcare professionals worldwide.

The company has received 44 FDA 510(k) clearances from 45 total submissions since 2004. Ophthalmic devices represent the dominant category, accounting for 71% of submissions. The latest clearance in 2025 reflects continued regulatory activity and product innovation in this specialized field.

Carl Zeiss Meditec's cleared device portfolio includes advanced diagnostic systems such as corneal topographers, optical biometers, and optical coherence tomography (OCT) systems. The company also manufactures ophthalmic microscopes, intraocular lenses, and surgical instruments for cataract and vitreoretinal procedures. These products support both diagnostic and surgical workflows in eye care.

Explore the complete list of device names, product codes, and individual clearance dates in the 510(k) database to review the company's full regulatory history.

Regulatory submissions have been managed by Carl Zeiss Meditec, Inc. and Carl Zeiss Meditec USA, Inc..