Medical Device Manufacturer · DE , Heidelberg

Heidelberg Engineering GmbH - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 2011

Recent clearances: ANTERION, SPECTRALIS HRA+OCT and variants, SPECTRALIS HRA+OCT and variants

18
Total
18
Cleared
0
Denied

Heidelberg Engineering GmbH has 18 FDA 510(k) cleared ophthalmic devices. Based in Heidelberg, DE.

Latest FDA clearance: Sep 2026. Active since 2011.

Browse the complete list of FDA 510(k) cleared ophthalmic devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Orasi Consulting, LLC and Mandell Horwitz Consultants, LLC. 7 devices have linked clinical trials registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Heidelberg Engineering GmbH

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