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Covidien FDA Approvals

0 new drug approvals and 18 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Sofsilk Coated Braided Silk Suture510(k)Dec 3, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Dec 3, 2024
Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044)510(k)Aug 20, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 20, 2024
GIA Stapler with Tri-Staple Technology510(k)Oct 27, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Oct 27, 2023
MaxTack Motorized Fixation Device510(k)Sep 8, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 8, 2023
Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)510(k)Aug 30, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Aug 30, 2023
TA Stapler and Loading Unit with DST Series Technology510(k)Aug 16, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 16, 2023
EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil510(k)Aug 16, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Aug 16, 2023
Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)510(k)Feb 22, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Feb 22, 2023
EEA Circular Stapler with Tri-Staple Technology510(k)Nov 30, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Nov 30, 2022
Signia Small Diameter Reloads Including Regular (Round) Tip Version510(k)Nov 29, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Nov 29, 2022
Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA510(k)Sep 30, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Sep 30, 2022
ProGrip Self-Gripping Polypropylene Mesh510(k)Sep 22, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Sep 22, 2022
VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula510(k)Jun 27, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 27, 2022
GIA Auto Suture Stapler with DST Series Technology510(k)May 5, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	May 5, 2022
GIA Stapler with Tri-Staple Technology510(k)Apr 29, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Apr 29, 2022
EEA Circular Stapler with Tri-Staple Technology510(k)Apr 29, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Apr 29, 2022
Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector510(k)Sep 17, 2021Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Sep 17, 2021
EEA Circular Stapler with Tri-Staple Technology510(k)Jan 21, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jan 21, 2021

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