Chrysalis Intelligence · Sponsors · Heidelberg Engineering GmbH

Heidelberg Engineering GmbH

Heidelberg, DE · 10 510(k) clearances · 1 recalls

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Total clearances

10

2020-09-09 → 2026-09-11

Last 12 months

2

Product codes

1

Most recent

2026-09-11

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
OBO	Tomography, Optical Coherence	Class II	Ophthalmic	10	2026-09-11

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

1

Most recent

2026-08-06

Date	Severity	Status	Recall #	Product	Code	Reason
2026-08-06	Class II	Ongoing	Z-3215-2026	Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, …	—	Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a res…

Filings

All 510(k) clearances (10)

Date	K-number	Device	Code	Class	Specialty
2026-09-11	K261019	ANTERION	OBO	Class II	Ophthalmic
2026-05-07	K253837	SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module	OBO	Class II	Ophthalmic
2025-05-12	K250868	SPECTRALIS HRA+OCT and variants	OBO	Class II	Ophthalmic
2024-12-13	K240924	Anterion	OBO	Class II	Ophthalmic
2024-10-11	K241163	SPECTRALIS with Flex Module	OBO	Class II	Ophthalmic
2024-07-01	K240221	SPECTRALIS HRA+OCT and variants	OBO	Class II	Ophthalmic
2023-10-20	K223557	SPECTRALIS HRA+OCT and variants	OBO	Class II	Ophthalmic
2023-10-11	K230897	Anterion	OBO	Class II	Ophthalmic
2021-11-05	K211817	Anterion	OBO	Class II	Ophthalmic
2020-09-09	K201252	Spectralis HRA+OCT and variants	OBO	Class II	Ophthalmic