Heidelberg Engineering GmbH
FDA 510(k) & PMA Approved Devices — 15 products
Total Devices15
Categories1
Latest FDA decision2026-05-07
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | OBO | 2026-05-07 | View |
| 510(k) | K250868 | SPECTRALIS HRA+OCT and variants | OBO | 2025-05-12 | View |
| 510(k) | K240924 | Anterion | OBO | 2024-12-13 | View |
| 510(k) | K241163 | SPECTRALIS with Flex Module | OBO | 2024-10-11 | View |
| 510(k) | K240221 | SPECTRALIS HRA+OCT and variants | OBO | 2024-07-01 | View |
| 510(k) | K223557 | SPECTRALIS HRA+OCT and variants | OBO | 2023-10-20 | View |
| 510(k) | K230897 | Anterion | OBO | 2023-10-11 | View |
| 510(k) | K211817 | Anterion | OBO | 2021-11-05 | View |
| 510(k) | K201252 | Spectralis HRA+OCT and variants | OBO | 2020-09-09 | View |
| 510(k) | K192391 | Spectralis HRA+OCT and Variants | OBO | 2019-09-26 | View |
| 510(k) | K182569 | Spectralis HRA+OCT and variants with High Magnification Module | OBO | 2018-10-18 | View |
| 510(k) | K181594 | Spectralis HRA+OCT and variants with OCT Angiography Module | OBO | 2018-09-13 | View |
| 510(k) | K173648 | Spectralis HRA + OCT and variants | OBO | 2018-08-30 | View |
| 510(k) | K172649 | Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor | OBO | 2017-11-01 | View |
| 510(k) | K152205 | Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor | OBO | 2016-05-06 | View |
No matching devices.