Heidelberg Engineering GmbH - FDA 510(k) Cleared Devices
Recent clearances: SPECTRALIS HRA+OCT and variants, SPECTRALIS HRA+OCT and variants, Anterion
17
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Heidelberg Engineering GmbH Ophthalmic ✕
17 devices
Cleared
CT
May 07, 2026
SPECTRALIS HRA+OCT and variants
Ophthalmic
157d
Cleared
CT
May 12, 2025
SPECTRALIS HRA+OCT and variants
Ophthalmic
49d
Cleared
Dec 13, 2024
Anterion
Ophthalmic
253d
Cleared
CT
Oct 11, 2024
SPECTRALIS with Flex Module
Ophthalmic
168d
Cleared
CT
Jul 01, 2024
SPECTRALIS HRA+OCT and variants
Ophthalmic
157d
Cleared
Oct 20, 2023
SPECTRALIS HRA+OCT and variants
Ophthalmic
329d
Cleared
Oct 11, 2023
Anterion
Ophthalmic
194d
Cleared
CT
Nov 05, 2021
Anterion
Ophthalmic
147d
Cleared
Sep 09, 2020
Spectralis HRA+OCT and variants
Ophthalmic
121d
Cleared
Sep 26, 2019
Spectralis HRA+OCT and Variants
Ophthalmic
23d
Cleared
Oct 18, 2018
Spectralis HRA+OCT and variants with High Magnification Module
Ophthalmic
30d
Cleared
CT
Sep 13, 2018
Spectralis HRA+OCT and variants with OCT Angiography Module
Ophthalmic
87d