Data / Medical devices / United States / OVIK Health

OVIK Health: FDA-registered device maker in Spartanburg, SC, United States, 7 510(k) clearances

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

OVIK Health is registered with the FDA (registration 3001186500) in Spartanburg, SC, United States. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 29, 2016. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3001186500
Address: 920 Milliken Rd, Spartanburg, SC, United States, 29303
Owner or operator: OVIK Health (9073743)
Roles: Complaint file establishment, Repackager or relabeler, Specification developer
First device listed: November 21, 2005
Registered through: 2026
Brand names listed: AFM Absorbent Pad, AFM Ag, AFM Ag Assist, AFM Ultra Ag, AGILE, ASSIST Absorbent Pad, ASSIST Silver, ComfortDry and more

Devices it lists

Device	Product code	Class	Role	Source
Dressing, Wound, Drug	FRO	U	Specification developer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Specification developer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Specification developer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Specification developer	accessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other Biologics	QSY	U	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Sheet, Burn	FPY	1	Specification developer	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
June 29, 2016	K160578	Nustat XR	QSY	Substantially Equivalent	Beeken Biomedical, LLC	accessdata.fda.gov
November 4, 2011	K110715	INTERDRY SILVER	FRL	Substantially Equivalent	Milliken Healthcare Products, LLC	accessdata.fda.gov
January 21, 2011	K103141	LOW ADHERENT AFM AG DRESSINGS	FRO	Substantially Equivalent	Milliken Healthcare Products, LLC	accessdata.fda.gov
February 17, 2010	K093188	AFM ULTRA AG DRESSINGS	FRO	Substantially Equivalent	Milliken & Co.	accessdata.fda.gov
April 16, 2009	K083659	SILVER WOUND PAD	FRO	Substantially Equivalent	Milliken & Co.	accessdata.fda.gov
December 10, 2007	K072890	STASILON FR	QSY	Substantially Equivalent	Entegrion, Inc.	accessdata.fda.gov
August 22, 2005	K051445	MILLIKEN SILVER WOUND DRESSINGS	FRO	Substantially Equivalent	Milliken Chemical	accessdata.fda.gov

Compare with other makers

Updated June 29, 2016. 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.