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Heidelberg Engineering GmbH

FDA 510(k) & PMA Approved Dispositivos — 16 products

Total de dispositivos16
Categorias0
Última decisão da FDA
TipoNúmeroNome do dispositivoCódigoDataAções
510(k) K261019 ANTERIONOBO2026-09-11 Ver
510(k) K253837 SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleOBO2026-05-07 Ver
510(k) K250868 SPECTRALIS HRA+OCT and variantsOBO2025-05-12 Ver
510(k) K240924 AnterionOBO2024-12-13 Ver
510(k) K241163 SPECTRALIS with Flex ModuleOBO2024-10-11 Ver
510(k) K240221 SPECTRALIS HRA+OCT and variantsOBO2024-07-01 Ver
510(k) K223557 SPECTRALIS HRA+OCT and variantsOBO2023-10-20 Ver
510(k) K230897 AnterionOBO2023-10-11 Ver
510(k) K211817 AnterionOBO2021-11-05 Ver
510(k) K201252 Spectralis HRA+OCT and variantsOBO2020-09-09 Ver
510(k) K192391 Spectralis HRA+OCT and VariantsOBO2019-09-26 Ver
510(k) K182569 Spectralis HRA+OCT and variants with High Magnification ModuleOBO2018-10-18 Ver
510(k) K181594 Spectralis HRA+OCT and variants with OCT Angiography ModuleOBO2018-09-13 Ver
510(k) K173648 Spectralis HRA + OCT and variantsOBO2018-08-30 Ver
510(k) K172649 Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with MulticolorOBO2017-11-01 Ver
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 MulticolorOBO2016-05-06 Ver
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