FDA applicant

Medcom GmbH

Darmstadt, Hessen, DE11 decisions2002–20180 recalls

FDA records 11 decisions for Medcom GmbH (Darmstadt, Hessen, DE) from 2002 to 2018: 11 510(k) clearances. Most are in product codes LHN (System, Radiation Therapy, Charged-Particle…) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 103 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 6 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, radiology panel, where it files most

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

FDA decisions per year

2in 2018

2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medcom GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Medcom”

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

Medcom Diagnostics, Inc. 2 Medcom Laundry Service, Inc. 1

Medcom GmbH

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Medcom”