Data / Medical devices / United States / Covidien

Covidien: FDA-registered device maker in Plainfield, IN, United States, 10 510(k) clearances

Name: Covidien FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Covidien is registered with the FDA (registration 3008361498) in Plainfield, IN, United States. It lists 9 device types. The FDA files 10 510(k) clearances under its listings, the newest dated July 21, 2023. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3008361498
Address: 2800 Airwest Blvd, Suite 160, Plainfield, IN, United States, 46168
Owner or operator: Covidien llc (1282497)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export
First device listed: May 2, 2000
Registered through: 2027
Brand names listed: Adapters, Adult-Neonatal Adhesive Sensor Wrap, Adult-Neonatal Foam Sensor Wrap, Bipolar Forceps Cord, Current Monitor E3350, Current Monitor E3351, Emprint Ablation System with Thermosphere Technology, Emprint Microwave Ablation System- CAMSYS and more

Devices it lists

Device	Product code	Class	Role	Source
Continuous Measurement Thermometer	FLL	2	Contract manufacturer	accessdata.fda.gov
Electrode, Electrosurgical	JOS	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer	accessdata.fda.gov
Oximeter, Ear	DPZ	2	Manufacturer	accessdata.fda.gov
System, Ablation, Microwave And Accessories	NEY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Gastrointestinal Motility (Electrical)	FFX	2	Manufacturer	accessdata.fda.gov
System, Imaging, Gastrointestinal, Wireless, Capsule	NEZ	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 21, 2023	K231861	EndoflipTM 300 System	FFX	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
August 26, 2020	K200796	Emprint Ablation System with Thermosphere Technology	NEY	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
April 28, 2014	K133821	EMPRINT ABLATION SYSTEM	NEY	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
August 12, 2013	K123864	GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM	NEZ	Substantially Equivalent	Given Imaging , Ltd.	accessdata.fda.gov
May 31, 2011	K110268	FORCETRIAD ELECTROSURGICAL GENERATOR	GEI	Substantially Equivalent	Covidien Lp, Formerly Know AS Valleylab, A Divison	accessdata.fda.gov
May 6, 2011	K102913	FORCETRIAD	GEI	Substantially Equivalent	Covidien, Formerly Valleylab, A Division of Tyco H	accessdata.fda.gov
March 7, 2002	K012891	OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)	DQA	Substantially Equivalent	Nellcor Puritan Bennett, Inc.	accessdata.fda.gov
March 11, 1997	K964636	FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM	GEI	Substantially Equivalent	Valleylab, Inc.	accessdata.fda.gov
April 23, 1993	K926415	VALLEYLAB CURRENT MONITOR, E3350 & E3351	GEI	Substantially Equivalent	Valleylab, Inc.	accessdata.fda.gov
May 20, 1980	K801153	VALLEYLAB RETURN ELECTRODE MONITOR	GEI	Substantially Equivalent	Valleylab, Inc.	accessdata.fda.gov

Compare with other makers

Updated July 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.