Medical Device Manufacturer · DE , Heidelberg

Heidelberg Engineering GmbH - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2011

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

17
Total
17
Cleared
0
Denied

Heidelberg Engineering GmbH has 17 FDA 510(k) cleared ophthalmic devices. Based in Heidelberg, DE.

Latest FDA clearance: May 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.

510(k) submissions have been managed by Orasi Consulting, LLC as regulatory consultant. 6 devices have linked clinical trials registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Heidelberg Engineering GmbH

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