Data / Medical devices / United States / Cardinal Health

Cardinal Health: FDA-registered device maker in Augusta, GA, United States, 12 510(k) clearances

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

Cardinal Health is registered with the FDA (registration 1018120) in Augusta, GA, United States. It lists 16 device types. The FDA files 12 510(k) clearances under its listings, the newest dated February 26, 2009. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1018120
Address: 1430 Marvin Griffin Rd, Augusta, GA, United States, 30906
Owner or operator: Cardinal Health 200, LLC (9028292)
Roles: Manufacturer, Repackager or relabeler
First device listed: August 4, 1999
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Bandage, Cast	ITG	1	Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Manufacturer	accessdata.fda.gov
Bandage, Liquid	KMF	1	Manufacturer	accessdata.fda.gov
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	MGQ	U	Manufacturer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Manufacturer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer	accessdata.fda.gov
Gauze/Sponge, Internal	EFQ	U	Manufacturer	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Manufacturer	accessdata.fda.gov
Pad, Alcohol, Device Disinfectant	LKB	U	Manufacturer	accessdata.fda.gov
Pad, Eye	HMP	1	Manufacturer	accessdata.fda.gov
Solvent, Adhesive Tape	KOX	1	Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Repackager or relabeler	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
February 26, 2009	K082296	COPA AMD	FRO	Substantially Equivalent	Covidien Lp, Formerly Registered AS Tyco Healthcar	accessdata.fda.gov
August 22, 2001	K011941	EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088	FRO	Substantially Equivalent	The Kendall Company	accessdata.fda.gov
January 31, 2000	K990530	KERLIX MD ANTIMICROBIAL GAUZE DRESSING	NAD	Substantially Equivalent	The Kendall Company, L.P.	accessdata.fda.gov
December 31, 1997	K973763	KENDALL CURITY IODOFORM PACKING STRIP	EFQ	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health	accessdata.fda.gov
December 16, 1997	K973511	KENDALL CURITY PETROLATUM GAUZE	FRO	Substantially Equivalent for Some Indications	Kendall Healthcare Products Co. Div.Of Tyco Health	accessdata.fda.gov
December 15, 1997	K973507	KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)	FRO	Substantially Equivalent for Some Indications	Kendall Healthcare Products Co. Div.Of Tyco Health	accessdata.fda.gov
December 10, 1997	K973619	KENDALL CURITY NON-ADHERING DRESSING	KMF	Substantially Equivalent for Some Indications	Kendall Healthcare Products Co. Div.Of Tyco Health	accessdata.fda.gov
April 3, 1995	K950775	CURASORB ZN ALGINATE WOUND DRESSING	KMF	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health	accessdata.fda.gov
January 27, 1995	K942394	SAFE VENT SYSTEM	FMF	Substantially Equivalent	Incutech, Inc.	accessdata.fda.gov
October 3, 1994	K943636	CURADERM ALGINATE HYDROCOLLOID	KMF	Substantially Equivalent for Some Indications	Kendall Healthcare Products Co. Div.Of Tyco Health	accessdata.fda.gov
July 26, 1994	K943073	CURAFIL WOUND GEL DRESSING	MGQ	Substantially Equivalent for Some Indications	Kendall Healthcare Products Co. Div.Of Tyco Health	accessdata.fda.gov
December 13, 1993	K933689	MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSING	KMF	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 17, 2017	78968	Class II	Terminated	Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity	Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and Ethylene Oxide sterilization.	accessdata.fda.gov

Compare with other makers

Updated February 26, 2009. 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.