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Heidelberg Engineering GmbH

17 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module (K253837)Heidelberg Engineering GmbH2026-05-07
SPECTRALIS HRA+OCT and variants (K250868)Heidelberg Engineering GmbH2025-05-12
Anterion (K240924)Heidelberg Engineering GmbH2024-12-13
SPECTRALIS with Flex Module (K241163)Heidelberg Engineering GmbH2024-10-11
SPECTRALIS HRA+OCT and variants (K240221)Heidelberg Engineering GmbH2024-07-01
SPECTRALIS HRA+OCT and variants (K223557)Heidelberg Engineering GmbH2023-10-20
Anterion (K230897)Heidelberg Engineering GmbH2023-10-11
Anterion (K211817)Heidelberg Engineering GmbH2021-11-05
Spectralis HRA+OCT and variants (K201252)Heidelberg Engineering GmbH2020-09-09
Spectralis HRA+OCT and Variants (K192391)Heidelberg Engineering GmbH2019-09-26
Spectralis HRA+OCT and variants with High Magnification Module (K182569)Heidelberg Engineering GmbH2018-10-18
Spectralis HRA+OCT and variants with OCT Angiography Module (K181594)Heidelberg Engineering GmbH2018-09-13
Spectralis HRA + OCT and variants (K173648)Heidelberg Engineering GmbH2018-08-30
Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor (K172649)Heidelberg Engineering GmbH2017-11-01
Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor (K152205)Heidelberg Engineering GmbH2016-05-06
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT (K121993)Heidelberg Engineering GmbH2012-10-25
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) (K113129)Heidelberg Engineering GmbH2011-11-08

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Every clearance here is in the API, with alerts when new ones post.