Data / Medical devices / United States / Z-Medica, LLC
Z-Medica, LLC: FDA-registered device maker in Wallingford, CT, United States, 8 510(k) clearances
Z-Medica, LLC is registered with the FDA (registration 3004138549) in Wallingford, CT, United States. It lists 3 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 18, 2025. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004138549
- Address
- 4 Fairfield BLVD., Wallingford, CT, United States, 06492
- Owner or operator
- Z-MEDICA, LLC (9048106)
- Roles
- Contract manufacturer, 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 | Contract manufacturer, Manufacturer | 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 22, 2021 | 88818 | Class II | Terminated | QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200 | Lack of Packaging seal integrity may result in a sterile barrier breach. | accessdata.fda.gov |
| November 17, 2017 | 79407 | Class II | Terminated | QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical | A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of "QuikClot TraumaPad" pouch. The carton as well as the remaining 9 pouches were properly identified as QuikClot Trauma Pad. The customer alleged that when the pouch was opened, it contained a QuikClot TraumaPad. All 10 pouches in the box had the correct part numb | accessdata.fda.gov |
| May 17, 2017 | 77316 | Class II | Terminated | QuikClot TraumaPad,, sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local manag | Packaging breach may compromise sterility | accessdata.fda.gov |
Compare with other makers
- All makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- All makers of Gauze / Sponge,Nonresorbable For External Use
- All makers of Temporary, Internal Use Hemostatic
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.