FDA applicant

Mallinckrodt Dar S.R.L.

Mirandola (Modena), IT2 decisions2000–20030 recalls

FDA records 2 decisions for Mallinckrodt Dar S.R.L. (Mirandola (Modena), IT) from 2000 to 2003: 2 510(k) clearances. Most are in product codes BSY (Catheters, Suction, Tracheobronchial) and BTT (Humidifier, Respiratory Gas, (Direct Patient…). Its devices cite 7 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, anesthesiology panel, where it files most

How often FDA has decided Mallinckrodt Dar S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mallinckrodt Dar S.R.L. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mallinckrodt Dar S.R.L. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mallinckrodt Dar S.R.L.’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 “Mallinckrodt”

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

Mallinckrodt Critical Care 92 Mallinckrodt Medical 43 Mallinckrodt Group, Inc. 27 Mallinckrodt Inc., Liebel-Flarsheim Business 8 Mallinckrodt Developpement France 7 Mallinckrodt Manufacturing, LLC 4 Mallinckrodt Medical Tpi, Inc. 4 Mallinckrodt Anesthesia Products 3 Mallinckrodt, Inc. 2 Mallinckrodt Sensor Systems, Inc. 2

Mallinckrodt Dar S.R.L.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Mallinckrodt”