Company profile

Covidien, LLC

Covidien, LLC has 2 AI-enabled medical devices on the FDA list. The first decision was on May 1, 2026 and the most recent on June 4, 2026 (Instrument Exit Point on Touch Surgery Aide). Its most common review panel is Gastroenterology-Urology (1 device).

2AI devices

2026First decision

2026Latest decision

2Specialties

Timeline

June 4, 2026 · 510(k) K253984Instrument Exit Point on Touch Surgery Aide · Gastroenterology-Urology · SFE
May 1, 2026 · 510(k) K253030Capnostream35 Portable Respiratory Monitor (PM35MN) · Anesthesiology · CCK