Medical Device Manufacturer · DE , Heidelberg

Heidelberg Engineering GmbH - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2011

Total

Cleared

Denied

Heidelberg Engineering GmbH has 16 FDA 510(k) cleared ophthalmic devices. Based in Heidelberg, DE.

Latest FDA clearance: May 2025. 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.

FDA 510(k) cleared devices by Heidelberg Engineering GmbH

16 devices

1-12 of 16

Cleared May 12, 2025

SPECTRALIS HRA+OCT and variants

SPECTRALIS with Flex Module

K241163 · OBO

Ophthalmic · 168d

Cleared Jul 01, 2024

SPECTRALIS HRA+OCT and variants

K240221 · OBO

Ophthalmic · 157d

Cleared Oct 20, 2023

SPECTRALIS HRA+OCT and variants

Spectralis HRA+OCT and variants

K201252 · OBO

Ophthalmic · 121d

Cleared Sep 26, 2019

Spectralis HRA+OCT and Variants

K192391 · OBO

Ophthalmic · 23d

Cleared Oct 18, 2018

Spectralis HRA+OCT and variants with High Magnification Module

K182569 · OBO

Ophthalmic · 30d

Cleared Sep 13, 2018

Spectralis HRA+OCT and variants with OCT Angiography Module

K181594 · OBO

Ophthalmic · 87d

Cleared Aug 30, 2018

Spectralis HRA + OCT and variants

K173648 · OBO

Ophthalmic · 276d

Heidelberg Engineering GmbH - FDA 510(k) Cleared Devices

FDA 510(k) cleared devices by Heidelberg Engineering GmbH

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