Heidelberg Engineering GmbH
Medical device manufacturer in Heidelberg, DE.
27510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261019 | AnterionOBO · Traditional | 09/11/2026SE |
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleOBO · Traditional | 05/07/2026SE |
| K250868 | SPECTRALIS HRA+OCT and variantsOBO · Traditional | 05/12/2025SE |
| K240924 | AnterionOBO · Traditional | 12/13/2024SE |
| K241163 | SPECTRALIS with Flex ModuleOBO · Traditional | 10/11/2024SE |
| K240221 | SPECTRALIS HRA+OCT and variantsOBO · Traditional | 07/01/2024SE |
| K223557 | SPECTRALIS HRA+OCT and variantsOBO · Traditional | 10/20/2023SE |
| K230897 | AnterionOBO · Traditional | 10/11/2023SE |
| K211817 | AnterionOBO · Traditional | 11/05/2021SE |
| K201252 | Spectralis HRA+OCT and variantsOBO · Traditional | 09/09/2020SE |
| K192391 | Spectralis HRA+OCT and VariantsOBO · Special | 09/26/2019SE |
| K182569 | Spectralis HRA+OCT and variants with High Magnification ModuleOBO · Special | 10/18/2018SE |
| K181594 | Spectralis HRA+OCT and variants with OCT Angiography ModuleOBO · Traditional | 09/13/2018SE |
| K173648 | Spectralis HRA + OCT and variantsOBO · Traditional | 08/30/2018SE |
| K172649 | Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis…OBO · Special | 11/01/2017SE |
| K152205 | Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT…OBO · Traditional | 05/06/2016SE |
| K121993 | Spectralis Hra + Oct and Variants, Spectralis Fa+ Oct, Spectralis Icga +Oct, Spectralis…OBO · Traditional | 10/25/2012SE |
| K113129 | Spectralis Anterior Segment Module (Spectralis Asm)OBO · Traditional | 11/08/2011SE |
| K101223 | Spectralis Hra+Oct, Spectralis Fa_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FaOBO · Traditional | 10/01/2010SE |
| K063191 | Heidelberg Retina Angiograph 2/OPTICAL Coherence Tomograph, Model Hra 2/OCTOBO · Traditional | 10/31/2006SE |
| K052935 | Heidelberg Engineering Slitlamp-Oct (Sl-Oct)MXK · Traditional | 01/13/2006SE |
| K042742 | Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM)MXK · Traditional | 10/13/2004SE |
| K971671 | Heidelberg Retina Angiograph Fa/Icga (Hra/C)HLI · Traditional | 07/29/1997SE |
| K944261 | Retina AngiographHLI · Traditional | 11/14/1994SE |
| K943956 | Retina Tomograph and FlowmeterHLI · Traditional | 11/14/1994SE |
| K943955 | Retina FlowmeterHLI · Traditional | 11/14/1994SE |
| K912891 | Heidelberg Retina TomographHLI · Traditional | 09/27/1991SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-3215-2026 | Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module…Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting… | 08/06/2026Open, Classified |
| Z-2437-2019 Class II | SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic…Error in the default configuration which could lead to the incorrect display of patient master data. | 07/03/2019Terminated |
| Z-1535-2018 Class II | Widefield OCT software feature for the Spectralis HRA+OCT and variantsFDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT… | 12/08/2017Terminated |