Covidien, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Covidien, LLC - FDA 510(k) Cleared Devices
Recent clearances: Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT), Instrument Exit Point on Touch Surgery™ Aide, Capnostream™35 Portable Respiratory Monitor (PM35MN)
Covidien, LLC has 87 FDA 510(k) cleared medical devices. Based in Mansfield, US.
Latest FDA clearance: Jul 2026. Active since 2010. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Covidien, LLC Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Regulatory Technology Services, LLC and Kompass Regulatory Consulting, LLC. 2 devices have linked clinical trials registered on ClinicalTrials.gov. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Covidien, LLC
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