Heidelberg Engineering GmbH
FDA Regulatory Profile
Heidelberg Engineering GmbH appears in FDA public data with 2 recalls, 26 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2437-2019, Class II) was initiated on July 3, 2019. Its most recent 510(k) clearance was granted on May 7, 2026.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 26
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2437-2019 | Class II | SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device | July 3, 2019 |
| Z-1535-2018 | Class II | Widefield OCT software feature for the Spectralis HRA+OCT and variants | December 8, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | May 7, 2026 |
| K250868 | SPECTRALIS HRA+OCT and variants | May 12, 2025 |
| K240924 | Anterion | December 13, 2024 |
| K241163 | SPECTRALIS with Flex Module | October 11, 2024 |
| K240221 | SPECTRALIS HRA+OCT and variants | July 1, 2024 |
| K223557 | SPECTRALIS HRA+OCT and variants | October 20, 2023 |
| K230897 | Anterion | October 11, 2023 |
| K211817 | Anterion | November 5, 2021 |
| K201252 | Spectralis HRA+OCT and variants | September 9, 2020 |
| K192391 | Spectralis HRA+OCT and Variants | September 26, 2019 |
| K182569 | Spectralis HRA+OCT and variants with High Magnification Module | October 18, 2018 |
| K181594 | Spectralis HRA+OCT and variants with OCT Angiography Module | September 13, 2018 |
| K173648 | Spectralis HRA + OCT and variants | August 30, 2018 |
| K172649 | Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, | November 1, 2017 |
| K152205 | Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis | May 6, 2016 |
| K121993 | SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEA | October 25, 2012 |
| K113129 | SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) | November 8, 2011 |
| K101223 | SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA | October 1, 2010 |
| K063191 | HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT | October 31, 2006 |
| K052935 | HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) | January 13, 2006 |