Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Covidien

FDA 510(k) & PMA Approved Devices — 61 products

Total Devices61
Categories20
Latest Approval2024-12-03
TypeNumberDevice NameCodeDate
510(k) K241486 Sofsilk™ Coated Braided Silk Suture GAP 2024-12-03 View
510(k) K240077 Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) FLL 2024-08-20 View
510(k) K231934 GIA™ Stapler with Tri-Staple™ Technology GAG 2023-10-27 View
510(k) K231240 MaxTack™ Motorized Fixation Device OCW 2023-09-08 View
510(k) K223130 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) BTR 2023-08-30 View
510(k) K231491 TA™ Stapler and Loading Unit with DST Series™ Technology GAG 2023-08-16 View
510(k) K232126 EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil GAG 2023-08-16 View
510(k) K221629 Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) GAG 2023-02-22 View
510(k) K221771 EEA Circular Stapler with Tri-Staple Technology GDW 2022-11-30 View
510(k) K222641 Signia™ Small Diameter Reloads Including Regular (Round) Tip Version GDW 2022-11-29 View
510(k) K221003 Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA GDW 2022-09-30 View
510(k) K220540 ProGrip Self-Gripping Polypropylene Mesh FTL 2022-09-22 View
510(k) K213818 VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula GCJ 2022-06-27 View
510(k) K221013 GIA Auto Suture Stapler with DST Series Technology GDW 2022-05-05 View
510(k) K221006 GIA Stapler with Tri-Staple Technology GDW 2022-04-29 View
510(k) K221005 EEA Circular Stapler with Tri-Staple Technology GDW 2022-04-29 View
510(k) K203762 Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector CCK 2021-09-17 View
510(k) K202507 EEA Circular Stapler with Tri-Staple Technology GDW 2021-01-21 View
510(k) K202701 GIA Stapler with Tri-Staple Technology GDW 2020-12-07 View
510(k) K202864 Tri-Staple 2.0 Reloads GDW 2020-10-28 View
510(k) K201805 VersaOne Reusable Positioning Trocar System GCJ 2020-08-26 View
510(k) K201672 Signia Stapler (with new software) GDW 2020-07-17 View
510(k) K193077 Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff JOH 2020-06-01 View
510(k) K192720 GIA Stapler with Tri-Staple Technology GDW 2020-03-13 View
510(k) K192330 EEA Circular Stapler with Tri-Staple Technology GDW 2020-01-23 View
510(k) K191070 Signia Small Diameter Reloads GDW 2019-09-04 View
510(k) K191601 Valleylab FT10 Electrosurgical Platform GEI 2019-07-12 View
510(k) K182861 Shiley Neonatal/Pediatric Tracheostomy Tube JOH 2019-03-22 View
510(k) K182475 Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) GDW 2019-03-14 View
510(k) K182772 Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil GEI 2018-11-19 View
510(k) K180622 Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port KNT 2018-10-23 View
510(k) K180496 TruClear Elite Hysteroscope HIH 2018-08-29 View
510(k) K180915 Sonicision Reusable Sterilization Tray KCT 2018-07-17 View
510(k) K181085 LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated GEI 2018-06-21 View
510(k) K181389 Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform GEI 2018-06-19 View
510(k) K173281 LigaSure Exact Dissector, Nano-coated GEI 2018-03-02 View
510(k) K173270 Tri-Staple 2.0 Reinforced Reload GDW 2018-02-20 View
510(k) K172361 EEA Circular Stapler with Tri-Staple Technology GDW 2018-02-16 View
510(k) K172482 The Nellcor pulse oximetry monitor interface cable DQA 2017-12-15 View
510(k) K162738 Puritan Bennett 980 Ventilator System CBK 2017-10-27 View
510(k) K170869 LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated GEI 2017-04-21 View
510(k) K170348 Signia Four-Bay Smart Charger (to be used with Signia Stapler) GDW 2017-03-02 View
510(k) K163620 Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves JOW 2017-01-19 View
510(k) K163055 Reprocessed Kendall SCD Express Foot Cuff JOW 2016-12-23 View
510(k) K163102 ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm GCJ 2016-11-30 View
510(k) K162941 Ligasure Blunt Tip, Sealer/Divider, Nano-coated GEI 2016-11-14 View
510(k) K160718 Vital Sync Informatics Manager & Virtual Patient Monitoring Platform MWI 2016-11-14 View
510(k) K162584 VersaOne Bladeless Trocar GCJ 2016-10-18 View
510(k) K161804 LigaSure Retractable L-Hook Laparoscopic Sealer/Divider GEI 2016-09-16 View
510(k) K162047 LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated GEI 2016-09-15 View
510(k) K161347 Signia sterilization tray KCT 2016-09-07 View
510(k) K161963 Monoject Enteral Syringe with ENFit Connector PNR 2016-09-01 View
510(k) K161105 Reprocessed Compression Garments JOW 2016-08-18 View
510(k) K160331 LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp GEI 2016-08-12 View
510(k) K153074 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal LZH 2016-07-06 View
510(k) K161045 Monoject PNR 2016-06-17 View
510(k) K160539 BiZact Open Sealer/Divider GEI 2016-06-15 View
510(k) K160419 Monoject Enteral Feeding Syringe with ENFit Connector PNR 2016-05-12 View
510(k) K160176 Signia Stapler GDW 2016-04-26 View
510(k) K160230 VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm GCJ 2016-03-01 View
510(k) K152149 VersaOne Bladed Trocar 5mm GCJ 2016-01-22 View