FDA applicant

Fujifilm Medwork GmbH

Hochstadt, DE2 decisions2021–20220 recalls

FDA records 2 decisions for Fujifilm Medwork GmbH (Hochstadt, DE) from 2021 to 2022: 2 510(k) clearances. All are in product code ODC (Endoscope Channel Accessory). Its devices cite 4 predicates, 1 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2022

2021high 1 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Fujifilm Medwork GmbH by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fujifilm Medwork 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 “Fujifilm”

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

Fujifilm Medical System U.S.A., Inc. 72 Fujifilm Corporation 71 Fujifilm Medical Systems U.S.A, Inc. 40 FUJIFILM Sonosite, Inc. 25 FUJIFILM Healthcare Americas Corporation 13 Fujifilm Healthcare Corporation 6 Fujifilm Corporaton 6 Fujifilm Irvine Scientific 5 Fujifilm New Development U.S.A., Inc. 3 Fujifilm Meidcal Systems U.S.A.,Inc. 2

Fujifilm Medwork GmbH

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Fujifilm”