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Unnamed device
Covidien llc
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
No dated reports to chart.
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — Covidien llc
- Warning Letter 2012-06-14 Covidien, LP
- Warning Letter 2012-06-14 Covidien, LP
- Warning Letter 2011-10-04 Oridion Medical 1987 Ltd.
- NAI 2025-07-16 Covidien LLC · 0 citations
- NAI 2025-07-16 Covidien LLC · 0 citations
- NAI 2024-11-21 Covidien, LP · 0 citations
- NAI 2024-11-21 Covidien, LP · 0 citations
- VAI 2022-11-18 Covidien LP · 1 citations
- VAI 2022-11-18 Covidien LP · 1 citations
- VAI 2022-09-08 Covidien · 0 citations
- VAI 2022-09-08 Covidien · 0 citations
- OAI 2022-04-28 Covidien · 2 citations
- OAI 2022-04-28 Covidien · 2 citations
- VAI 2020-02-28 Covidien, LP · 1 citations
- VAI 2020-02-28 Covidien, LP · 1 citations
- NAI 2018-09-19 Covidien · 0 citations
- NAI 2018-09-19 Covidien · 0 citations
- VAI 2017-09-22 Covidien, LLC · 2 citations
- VAI 2017-09-22 Covidien, LLC · 2 citations
- NAI 2017-08-09 Covidien · 0 citations
- NAI 2017-08-09 Covidien · 0 citations
- NAI 2016-10-31 Covidien · 0 citations
- NAI 2016-10-31 Covidien · 0 citations