Covidien, LLC - FDA 510(k) Cleared Devices
88
Total
85
Cleared
1
Denied
88 devices
Cleared
Nov 20, 2020
Puritan Bennett 980 Series Ventilator System
Anesthesiology
385d
Cleared
Aug 26, 2020
Emprint Ablation System with Thermosphere Technology
General & Plastic Surgery
153d
Cleared
Jul 20, 2020
GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
Anesthesiology
80d
Cleared
Jul 10, 2020
Sonicision Cordless Ultrasonic Dissector
General & Plastic Surgery
140d
Cleared
May 07, 2020
HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor
General & Plastic Surgery
106d
Cleared
Mar 02, 2020
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
Ear, Nose, Throat
89d
Cleared
Feb 13, 2020
Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation...
General & Plastic Surgery
80d
Cleared
Jan 17, 2020
Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter,...
Gastroenterology & Urology
147d
Cleared
Dec 02, 2019
Emprint Visualization Application
Radiology
125d
Cleared
Aug 07, 2019
ILLUMISITE Platform
Radiology
75d
Cleared
Jan 08, 2019
INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
General & Plastic Surgery
88d
Cleared
Nov 06, 2018
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
Ear, Nose, Throat
60d
Cleared
Aug 16, 2018
Cytosponge Cell Collection Device
Gastroenterology & Urology
121d
Cleared
Jul 27, 2018
Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal...
Gastroenterology & Urology
154d
Cleared
Apr 26, 2018
Beacon EUS Access System
Gastroenterology & Urology
111d
Cleared
Mar 26, 2018
Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision...
General & Plastic Surgery
66d
Cleared
Mar 21, 2018
Emprint Ablation Visualization Application
Radiology
56d
Cleared
Feb 08, 2018
superDimension Navigation System V7.2
Radiology
125d
Cleared
Jan 18, 2018
Barrx SB RFA Endoscopic Catheter
Gastroenterology & Urology
62d
Cleared
Nov 02, 2017
Valleylab FX8 Electrosurgical Platform
General & Plastic Surgery
50d
Cleared
Jun 08, 2017
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
General & Plastic Surgery
59d
Cleared
Apr 21, 2017
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
Ear, Nose, Throat
126d
Cleared
Mar 08, 2017
VersaOne fascial closure system bladed trocar, VersaOne fascial closure...
General & Plastic Surgery
75d
Cleared
Feb 16, 2017
Valleylab FT10 Electrosurgical Platform
General & Plastic Surgery
28d
Cleared
Jan 24, 2017
Barrx Anorectal RFA Wand
General & Plastic Surgery
111d
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