Company ยท US
Z-Medica, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2022. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 14, 2022 | K220971 | QuikClot Control+ Hemostatic Dressing Z-Medica, LLC | POD |
| Apr 23, 2020 | K200167 | QuikClot Control+ Z-Medica, LLC | POD |
| Dec 24, 2018 | K181641 | QuikClot Radial Z-Medica, LLC | QSY |
| Jun 30, 2017 | DEN160012 | D2 Dressing Z-Medica, LLC | POD |
| Jul 17, 2014 | K140757 | D2 HEMOSTANTIC DRESSING Z-Medica, LLC | QSY |
| Apr 12, 2013 | K123387 | QUIKCLOT HEMOSTATIC DRESSING Z-Medica, LLC | QSY |
| Mar 20, 2013 | K120782 | INTERVENTIONAL HEMOSTATIC BANDAGE Z-Medica Corporation | QSY |
| Apr 8, 2009 | K090620 | QUIKCLOT INTEVENTIONAL, MODEL P/N 182 Z-Medica Corporation | QSY |
| Feb 27, 2008 | K080247 | QUIKCLOT NOSEBLEED Z-Medica Corporation | LYA |
| Oct 16, 2007 | K072474 | QUIKCLOT EX Z-Medica Corporation | QSY |
| Jan 25, 2007 | K070010 | QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER Z-Medica Corporation | QSY |
| Jul 19, 2006 | K061767 | QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+ Z-Medica Corporation | QSY |
| Aug 10, 2005 | K051955 | QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE Z-Medica Corporation | QSY |
| Apr 14, 2005 | K050769 | QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172 Z-Medica Corporation | QSY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2021 | Z-Medica, LLC QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding
Model / Part# 200 Terminated |
FRO | K072474 |
| Nov 17, 2017 | Z-Medica, LLC 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 woun Terminated |
FRO | K123387 |
| May 17, 2017 | Z-Medica, LLC 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 topica Terminated |
FRO | K123387 |