Covidien, LLC
FDA 510(k) medical device clearances.
Top product codes for Covidien, LLC
Recent clearances by Covidien, LLC
- K253527 — Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)
- K253984 — Instrument Exit Point on Touch Surgery Aide
- K253030 — Capnostream35 Portable Respiratory Monitor (PM35MN)
- K251025 — Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
- 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
- K250725 — Hugo RAS System
- 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)
- 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
- K241085 — Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)
- 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)
- 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)
- K230693 — BIS Advance Monitoring System
- K231861 — EndoflipTM 300 System
- K223705 — EndoflipTM 300
- K223158 — LigaSure XP Maryland Jaw Sealer/Divider
- K213911 — Microstream CO2 NanoPod
- DEN220006 — ProdiGI
- K212555 — Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC
- K213518 — CARESCAPE CO2 Microstream parameter
- K203150 — Cool-tip RF Ablation System E Series
- K213602 — Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
- K211561 — INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
- K212301 — Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
- K210338 — Edge Insulated Blade Electrode
- K202917 — LigaSure Exact Dissector, Nano-coated
- K202874 — Puritan Bennett Cuff Pressure Manager
- K203303 — Emprint SX Ablation Platform with Thermosphere Technology
- K193056 — Puritan Bennett 980 Series Ventilator System
- K200796 — Emprint Ablation System with Thermosphere Technology
- K201179 — GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
- K200427 — Sonicision Cordless Ultrasonic Dissector
- K200146 — HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor
- K193356 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
- K193232 — Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
- K192302 — Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
- K192038 — Emprint Visualization Application
- K191394 — ILLUMISITE Platform
- K182868 — INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
- K182451 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
- K181020 — Cytosponge Cell Collection Device
- K180485 — Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
- K180037 — Beacon EUS Access System
- K180149 — Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
- K180192 — Emprint Ablation Visualization Application
- K173244 — superDimension Navigation System V7.2
- K173559 — Barrx SB RFA Endoscopic Catheter
- K172757 — Valleylab FX8 Electrosurgical Platform
- K171066 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
- K163537 — Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
- K163654 — VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar
- K170170 — Valleylab FT10 Electrosurgical Platform
- K162802 — Barrx Anorectal RFA Wand
- K163105 — Emprint Ablation System
- K163098 — Tri-Staple 2.0 Intelligent Cartridge
- K160290 — Valleylab REM Polyhesive Infant Patient Return Electrode
- K160654 — GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
- K152794 — Cytosponge Cell Collection Device
- K160360 — Barrx FLEX RFA Energy Generator
- K153371 — Sonicision Cordless Ultrasonic Dissection Device
- K152586 — Beacon Fine Needle Fiducial System
- K151376 — superDimension Navigation System
- K150251 — Barrx Anorectal RFA Wand
- K151659 — ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks
- K151356 — Spacemaker Pro Access and Dissector System
- K151163 — Signia Loading Unit, Tri-Staple 2.0 Cartridge
- K142839 — GenCut Core Biopsy System
- K143654 — Valleylab LS10 Generator
- K142865 — Nellcor Bedside SpO2 Patient Monitoring System
- K143598 — Lapro-Clip Auto Suture Reusable Long Clip Applier
- K142695 — Cytosponge Cell Collection Device
- K143091 — Surgisleeve Wound Protector
- K142654 — Fortrex 0.035 OTW PTA Balloon Catheter
- K141801 — HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
- K142198 — BNX Fine Needle Aspiration System
- K141542 — NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
- K142364 — Barrx RFA Self Sizing Balloon Catheter
- K142048 — EMPRINT PROCEDURE PLANNING APPLICATION
- K133821 — EMPRINT ABLATION SYSTEM
- K133762 — ENDO GIA(TM) EXTRA LONG ADAPTER
- K130357 — SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
- K132493 — ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
- K130623 — BARRX CHANNEL RFA ENDOSCOPIC CATHETER
- K130782 — ACCUMESH DEPLOYMENT SYSTEM
- K123066 — ACCUMESH DEPLOYMENT SYSTEM
- K120773 — NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM
- K120605 — PERMACOL SURGICAL IMPLANT
- K121139 — ACCUMESH DEPLOYMENT SYSTEM
- K120863 — WHOLEY GUIDE WIRE SYSTEM
- K103052 — V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE
- K102737 — KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
Data sourced from openFDA. This site is unofficial and independent of the FDA.