Data / Medical devices / United States / Z-Medica, LLC

Z-Medica, LLC: FDA-registered device maker in North Haven, CT, United States, 8 510(k) clearances

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

Z-Medica, LLC is registered with the FDA (registration 3015437221) in North Haven, CT, United States. It lists 3 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 18, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015437221
Address: 222 Universal Drive Distribution Facility Only, North Haven, CT, United States, 06473
Owner or operator: Z-MEDICA, LLC (9048106)
Roles: Manufacturer, Repackager or relabeler
First device listed: November 14, 2007
Registered through: 2026
Brand names listed: Phokus Nonwoven Bandage, QuickClot Control+ Hemostatic Device, QuikClot Combat Gauze, QuikClot EMS, QuikClot Combat Gauze TraumaPad, QuikClot Bleeding Control Dressing, QuikClot Control+, QuikClot Hemostatic Dressings, QuikClot 2x2, QuikClot 4x4, QuikClot TraumaPad, QuikClot Z-Fold, QuikClot Roll, QuikClot Interventional, QuikClot Radial

Devices it lists

Device	Product code	Class	Role	Source
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other Biologics	QSY	U	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Temporary, Internal Use Hemostatic	POD	2	Manufacturer, Repackager or relabeler	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
March 18, 2025	K243553	QuikClot Control+ Hemostatic Device	POD	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
December 14, 2022	K220971	QuikClot Control+ Hemostatic Dressing	POD	Substantially Equivalent	Z-Medica, LLC	accessdata.fda.gov
December 24, 2018	K181641	QuikClot Radial	QSY	Substantially Equivalent	Z-Medica, LLC	accessdata.fda.gov
June 30, 2017	DEN160012	D2 Dressing	POD	Unknown	Z-Medica, LLC	accessdata.fda.gov
April 12, 2013	K123387	QUIKCLOT HEMOSTATIC DRESSING	QSY	Substantially Equivalent	Z-Medica, LLC	accessdata.fda.gov
March 20, 2013	K120782	INTERVENTIONAL HEMOSTATIC BANDAGE	QSY	Substantially Equivalent	Z-Medica Corporation	accessdata.fda.gov
April 8, 2009	K090620	QUIKCLOT INTEVENTIONAL, MODEL P/N 182	QSY	Substantially Equivalent	Z-Medica Corporation	accessdata.fda.gov
October 16, 2007	K072474	QUIKCLOT EX	QSY	Substantially Equivalent	Z-Medica Corporation	accessdata.fda.gov

Compare with other makers

Updated March 18, 2025. 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.