Medical Device Manufacturer · DE , Heidelberg

Heidelberg Engineering GmbH

16 submissions · 16 cleared · Since 2011
16
Total
16
Cleared
0
Denied

Heidelberg Engineering GmbH — FDA 510(k) Submissions

Heidelberg Engineering GmbH has submitted 16 FDA 510(k) premarket notifications since 2011, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Tomography, Optical Coherence . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
SPECTRALIS HRA+OCT and variants
K250868 · OBO Tomography, Optical... · Ophthalmic
May 2025 49d
Anterion
K240924 · OBO Tomography, Optical... · Ophthalmic
Dec 2024 253d
SPECTRALIS with Flex Module
K241163 · OBO Tomography, Optical... · Ophthalmic
Oct 2024 168d
SPECTRALIS HRA+OCT and variants
K240221 · OBO Tomography, Optical... · Ophthalmic
Jul 2024 157d
SPECTRALIS HRA+OCT and variants
K223557 · OBO Tomography, Optical... · Ophthalmic
Oct 2023 329d
Anterion
K230897 · OBO Tomography, Optical... · Ophthalmic
Oct 2023 194d
Anterion
K211817 · OBO Tomography, Optical... · Ophthalmic
Nov 2021 147d
Spectralis HRA+OCT and variants
K201252 · OBO Tomography, Optical... · Ophthalmic
Sep 2020 121d
Spectralis HRA+OCT and Variants
K192391 · OBO Tomography, Optical... · Ophthalmic
Sep 2019 23d
Spectralis HRA+OCT and variants with High Magnification Module
K182569 · OBO Tomography, Optical... · Ophthalmic
Oct 2018 30d
Spectralis HRA+OCT and variants with OCT Angiography Module
K181594 · OBO Tomography, Optical... · Ophthalmic
Sep 2018 87d
Spectralis HRA + OCT and variants
K173648 · OBO Tomography, Optical... · Ophthalmic
Aug 2018 276d
Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor
K172649 · OBO Tomography, Optical... · Ophthalmic
Nov 2017 57d
Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor
K152205 · OBO Tomography, Optical... · Ophthalmic
May 2016 274d
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT
K121993 · OBO Tomography, Optical... · Ophthalmic
Oct 2012 111d
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)
K113129 · OBO Tomography, Optical... · Ophthalmic
Nov 2011 15d
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