FDA 510(k) Applications Submitted by COVIDIEN

FDA 510(k) Number Submission Date Device Name Applicant
K141153 05/05/2014 LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED COVIDIEN
K121194 04/19/2012 ENDO CLIP III 5MM CLIP APPLIER COVIDIEN
K132360 07/30/2013 KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER COVIDIEN
K140339 02/10/2014 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM COVIDIEN
K180915 04/09/2018 Sonicision Reusable Sterilization Tray Covidien
K170869 03/23/2017 LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated Covidien
K181389 05/25/2018 Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform Covidien
K162047 07/25/2016 LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated COVIDIEN
K142929 10/09/2014 Ligasure Blunt Tip Sealer/Divider COVIDIEN
K173281 10/16/2017 LigaSure Exact Dissector, Nano-coated Covidien
K162941 10/21/2016 Ligasure Blunt Tip, Sealer/Divider, Nano-coated COVIDIEN
K140609 03/10/2014 RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS COVIDIEN
K140813 04/01/2014 REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES COVIDIEN
K131614 06/03/2013 REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM COVIDIEN
K111887 07/01/2011 CLOSUREFAST RADIOFREQUENCY CATHETER COVIDIEN
K150844 03/30/2015 Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula COVIDIEN
K151381 05/22/2015 Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye Covidien
K142296 08/18/2014 Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula Covidien
K112536 09/01/2011 SONICISION STERILIZATION TRAY COVIDIEN
K152286 08/13/2015 LigaSure Curved, Small Jaw, Open Sealer/Divider COVIDIEN
K161804 06/30/2016 LigaSure Retractable L-Hook Laparoscopic Sealer/Divider COVIDIEN
K143088 10/28/2014 GastriSail Gastric Positioning System COVIDIEN
K142934 10/09/2014 CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved COVIDIEN
K130744 03/19/2013 LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER COVIDIEN
K132567 08/15/2013 ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN COVIDIEN
K130320 02/08/2013 BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW COVIDIEN
K121806 06/20/2012 BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE COVIDIEN
K160176 01/27/2016 Signia Stapler Covidien
K180496 02/26/2018 TruClear Elite Hysteroscope Covidien
K160331 02/08/2016 LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp Covidien
K181085 04/25/2018 LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated Covidien
K141518 06/09/2014 Nellcor Bedside Respiratory Patient Monitoring System COVIDIEN
K111933 07/08/2011 COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 COVIDIEN
K090470 02/23/2009 AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES COVIDIEN
K120944 03/29/2012 KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER COVIDIEN
K130904 04/01/2013 TRELLIS-8 PERIPHERAL INFUSION SYSTEM COVIDIEN
K123196 10/11/2012 PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH COVIDIEN
K163055 11/01/2016 Reprocessed Kendall SCD Express Foot Cuff COVIDIEN
K150711 03/19/2015 Salem Sump Dual Lumen Stomach Tube with Multi-functional Port COVIDIEN
K123555 11/19/2012 KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY COVIDIEN
K142335 08/21/2014 RapidVac Smoke Evacuator System COVIDIEN
K133938 12/23/2013 ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY COVIDIEN
K153074 10/22/2015 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal COVIDIEN
K143263 11/13/2014 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets COVIDIEN
K170348 02/03/2017 Signia Four-Bay Smart Charger (to be used with Signia Stapler) Covidien
K161347 05/16/2016 Signia sterilization tray COVIDIEN
K163102 11/07/2016 ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm COVIDIEN
K130796 03/22/2013 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM COVIDIEN
K142298 08/18/2014 Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff Covidien
K132604 08/20/2013 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM COVIDIEN
K162738 09/30/2016 Puritan Bennett 980 Ventilator System Covidien
K141858 07/10/2014 CLOSURERFG RADIOFREQUENCY GENERATOR COVIDIEN
K142547 09/10/2014 Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm COVIDIEN
K142656 09/18/2014 Surgical Gut Suture COVIDIEN
K100306 02/03/2010 KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES COVIDIEN
K172482 08/16/2017 The Nellcor pulse oximetry monitor interface cable Covidien
K131252 05/02/2013 PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM COVIDIEN
K140064 01/10/2014 SURGISLEEVE WOUND PROTECTOR COVIDIEN
K152565 09/09/2015 Auto Suture Locking Trocar COVIDIEN
K142869 10/01/2014 Premium Surgiclip III COVIDIEN
K143644 12/22/2014 Premium Surgiclip?; Endo Clip?; AcuClip? COVIDIEN
K091762 06/16/2009 DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE COVIDIEN
K150735 03/20/2015 Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot COVIDIEN
K150835 03/30/2015 LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip COVIDIEN
K163620 12/22/2016 Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves Covidien
K173270 10/12/2017 Tri-Staple 2.0 Reinforced Reload Covidien
K123109 10/04/2012 ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE COVIDIEN
K072814 10/01/2007 CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES COVIDIEN
K172361 08/04/2017 EEA Circular Stapler with Tri-Staple Technology Covidien
K083325 11/12/2008 N-600X WITH SPD, OXIMAX N-600X COVIDIEN
K142128 08/04/2014 KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR COVIDIEN
K160539 02/26/2016 BiZact Open Sealer/Divider COVIDIEN
K151649 06/18/2015 Valleylab FT10 Electrosurgical Platform COVIDIEN
K143161 11/03/2014 Force FX-8(S), Force FX-8C(S), Force FX-8CA(S) COVIDIEN
K150084 01/15/2015 Argyle? Polyvinyl Chloride (PVC) and Kangaroo? Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector COVIDIEN
K160419 02/16/2016 Monoject Enteral Feeding Syringe with ENFit Connector COVIDIEN
K161045 04/13/2016 Monoject Covidien
K161963 07/18/2016 Monoject Enteral Syringe with ENFit Connector COVIDIEN
K131361 05/13/2013 WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET COVIDIEN
K123083 10/01/2012 COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT COVIDIEN
K090352 02/11/2009 TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES COVIDIEN
K122531 08/20/2012 SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T COVIDIEN
K141479 06/04/2014 KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS COVIDIEN
K102291 08/12/2010 COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY COVIDIEN
K160718 03/15/2016 Vital Sync Informatics Manager & Virtual Patient Monitoring Platform COVIDIEN
K143506 12/10/2014 BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL COVIDIEN
K160230 02/01/2016 VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm COVIDIEN
K151548 06/09/2015 VersaOne Bladed Trocar, VersaOne Bladeless Trocar COVIDIEN
K152149 08/03/2015 VersaOne Bladed Trocar 5mm COVIDIEN
K162584 09/16/2016 VersaOne Bladeless Trocar COVIDIEN
K082322 08/13/2008 AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS COVIDIEN
K082454 08/26/2008 MICROMYST APPLICATOR, MODEL 20-5000 COVIDIEN
K143018 10/20/2014 Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors Covidien
K100418 02/16/2010 SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE COVIDIEN
K120674 03/05/2012 MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER COVIDIEN
K161105 04/19/2016 Reprocessed Compression Garments COVIDIEN
K111372 05/16/2011 TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... COVIDIEN
K111817 06/27/2011 PALINDROME RT CHRONIC CATHETER COVIDIEN
K112477 08/29/2011 PALINDROME H, SI, HSI CHRONIC CATHETER COVIDIEN


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact