FDA applicant

Richter & Rothe AG

Leipzig, DE1 decision2006–20060 recalls

FDA records 1 decision for Richter & Rothe AG (Leipzig, DE) in 2006: 1 510(k) clearance. All are in product code MJN (Catheter, Intravascular Occluding, Temporary). Its devices cite 2 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, cardiovascular panel, where it files most

How often FDA has decided Richter & Rothe AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Richter & Rothe AG since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Richter & Rothe AG’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 “Richter”

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

Richter Rubber Technology Sbn Bhd 1 Richter Rubber Technology Sdn. Bhd. 1

Richter & Rothe AG

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Richter”