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Heidelberg Engineering GmbH FDA Approvals

0 new drug approvals and 9 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
ANTERION510(k)Sep 11, 2026Ophthalmic
SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module510(k)May 7, 2026Ophthalmic
SPECTRALIS HRA+OCT and variants510(k)May 12, 2025Ophthalmic
Anterion510(k)Dec 13, 2024Ophthalmic
SPECTRALIS with Flex Module510(k)Oct 11, 2024Ophthalmic
SPECTRALIS HRA+OCT and variants510(k)Jul 1, 2024Ophthalmic
SPECTRALIS HRA+OCT and variants510(k)Oct 20, 2023Ophthalmic
Anterion510(k)Oct 11, 2023Ophthalmic
Anterion510(k)Nov 5, 2021Ophthalmic

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