FDA applicant

Vitromed GmbH

Langenfeld, DE7 decisions2020–20250 recalls

FDA records 7 decisions for Vitromed GmbH (Langenfeld, DE) from 2020 to 2025: 7 510(k) clearances. Most are in product codes MQL (Media, Reproductive) and MQH (Microtools, Assisted Reproduction (Pipettes)). Since 2016 its 510(k)s took a median of 258 days from receipt to decision, against 199 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Vitromed GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020high 2 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Vitromed GmbH by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vitromed GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Vitromed”

FDA records each applicant name separately; these may or may not be the same firm.

Vitromed Langenfeld 1

Vitromed GmbH

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Vitromed”