Covidien, LLC
FDA 510(k) & PMA Approved Devices — 58 products
Total Devices58
Categories27
Latest FDA decision2026-07-01
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253527 | Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | GAG | 2026-07-01 | View |
| 510(k) | K253984 | Instrument Exit Point on Touch Surgery™ Aide | SFE | 2026-06-04 | View |
| 510(k) | K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | CCK | 2026-05-01 | View |
| 510(k) | K251313 | Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT | JOH | 2025-12-29 | View |
| 510(k) | K251025 | Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | BZT | 2025-12-29 | View |
| 510(k) | K250725 | Hugo™ RAS System | SCV | 2025-12-03 | View |
| 510(k) | K250173 | Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) | BTR | 2025-10-06 | View |
| 510(k) | K243785 | Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced | BTR | 2025-09-25 | View |
| 510(k) | K241085 | Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) | GEI | 2024-07-12 | View |
| 510(k) | K240572 | Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 15’ (4.6m) (VSMP15); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab™ SM Smoke Management Extended Nozzle (for use with 4” (100mm) electrode) (VSMEN4); Valleylab™ SM Smoke Management Extended Nozzle (for use with 6.5” (165mm) electrode) (VSMEN6) | GEI | 2024-07-01 | View |
| 510(k) | K233341 | Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) | BTR | 2024-05-20 | View |
| 510(k) | K230693 | BIS™ Advance Monitoring System | OLW | 2024-02-26 | View |
| 510(k) | K231861 | EndoflipTM 300 System | FFX | 2023-07-21 | View |
| 510(k) | K223705 | EndoflipTM 300 | FFX | 2023-04-14 | View |
| 510(k) | K223158 | LigaSure™ XP Maryland Jaw Sealer/Divider | GEI | 2023-01-23 | View |
| 510(k) | K213911 | Microstream CO2 NanoPod | CCK | 2022-07-29 | View |
| 510(k) | K212555 | Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC | DQA | 2022-05-06 | View |
| 510(k) | K213518 | CARESCAPE CO2 Microstream parameter | CCK | 2022-04-12 | View |
| 510(k) | K203150 | Cool-tip RF Ablation System E Series | GEI | 2022-02-25 | View |
| 510(k) | K213602 | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit | FJS | 2022-01-14 | View |
No matching devices.
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