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Sign in to claim this brandZ-Medica, LLC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 222 Universal Drive, North Haven, CT, 06473
- Website
- teleflex.com
- —
- —
- [email protected]
- Phone
- 877-750-0504
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3015437221
- DUNS Number
- 079190073
Catalogue (61)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Quikclot 1st Response & Quikclot Acs+ | K061767 | FDA 510(k) | U | Active |
| D2 Hemostantic Dressing | K140757 | FDA 510(k) | U | Active |
| QuikClot Control+ | K200167 | FDA 510(k) | Class II | Active |
| Quikclot Ex | K072474 | FDA 510(k) | U | Active |
| D2 Dressing | DEN160012 | FDA 510(k) | Class II | Active |
| Quikclot Nosebleed | K080247 | FDA 510(k) | Class I | Active |
| QuikClot Control+ Hemostatic Dressing | K220971 | FDA 510(k) | Class II | Active |
| Quikclot Hemostatic Dressing | K123387 | FDA 510(k) | U | Active |
| Quikclot Brand Hemostatic Agent - Advanced Beaded Formulation - 100g - 1.9mm - 2.4mm., Model 100172 | K050769 | FDA 510(k) | U | Active |
| Quikclot Sport And Quikclot Sport Silver | K070010 | FDA 510(k) | U | Active |
| QuikClot Radial | K181641 | FDA 510(k) | U | Active |
Related Companies
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 22, 2021 | Z-0211-2022 | — | terminated | Lack of Packaging seal integrity may result in a sterile barrier breach. |
| Nov 17, 2017 | Z-0925-2018 | — | terminated | 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 number, lot number, and expiration date for the prod uct (QuikClot TraumaPad). |
| May 17, 2017 | Z-2612-2017 | — | terminated | Packaging breach may compromise sterility |