Data / Medical devices / United States / Facet Technologies, LLC.

Facet Technologies, LLC.: FDA-registered device maker in Atlanta, GA, United States, 3 510(k) clearances

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

Facet Technologies, LLC. is registered with the FDA (registration 3011617315) in Atlanta, GA, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 28, 2022. 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: 3011617315
Address: 3900 North Commerce Drive, Atlanta, GA, United States, 30344
Owner or operator: FACET TECHNOLOGIES, LLC (9093801)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: October 20, 2006
Registered through: 2026
Brand names listed: CareFine Pen Needles, SureSeal

Devices it lists

Device	Product code	Class	Role	Source
Multiple Use Blood Lancet For Single Patient Use Only	QRL	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	QRK	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Complaint file establishment, 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
November 28, 2022	K223099	Facet Manatee Reusable Lancing Base	QRL	Substantially Equivalent	Facet Technologies, LLC	accessdata.fda.gov
July 15, 2022	K221433	Facet 28G Universal Lancet	QRK	Substantially Equivalent	Facet Technologies, LLC	accessdata.fda.gov
May 13, 2014	K140568	CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT	FMI	Substantially Equivalent	Facet Technologies, LLC	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 18, 2008	49360	Not yet classified	Terminated	Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing Device, 1 Clear Cap and 5 Premier Value Ultra Thin Lancets, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL 33431. Lancing	The Alternate Site Cap was not included in the package as indicated on the labeling.	accessdata.fda.gov

Compare with other makers

Updated November 28, 2022. 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.