Heidelberg Engineering GmbH
Heidelberg Engineering GmbH holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2026, with 1 FDA device recall on record.
Top product codes for Heidelberg Engineering GmbH
FDA recalls by Heidelberg Engineering GmbH
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Heidelberg Engineering GmbH
- K261019 — ANTERION
- K253837 — SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module
- K250868 — SPECTRALIS HRA+OCT and variants
- K240924 — Anterion
- K241163 — SPECTRALIS with Flex Module
- K240221 — SPECTRALIS HRA+OCT and variants
- K223557 — SPECTRALIS HRA+OCT and variants
- K230897 — Anterion
- K211817 — Anterion
- K201252 — Spectralis HRA+OCT and variants
- K192391 — Spectralis HRA+OCT and Variants
- K182569 — Spectralis HRA+OCT and variants with High Magnification Module
- K181594 — Spectralis HRA+OCT and variants with OCT Angiography Module
- K173648 — Spectralis HRA + OCT and variants
- K172649 — Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor
- K152205 — Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor
- K121993 — SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT
- K113129 — SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)
Data sourced from openFDA. This site is unofficial and independent of the FDA.