Z-Medica, LLC
Wallingford, CT, US
Z-MEDICA, LLC appears in FDA device records in Wallingford, CT. FDA records list 14 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Z-Medica, LLC between 2005 and 2022. The busiest year on record is 2005, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220971 | QuikClot Control+ Hemostatic Dressing | POD | Substantially Equivalent | |
| K200167 | QuikClot Control+ | POD | Substantially Equivalent | |
| K181641 | QuikClot Radial | QSY | Substantially Equivalent | |
| DEN160012 | D2 Dressing | POD | Unknown | |
| K140757 | D2 HEMOSTANTIC DRESSING | QSY | Substantially Equivalent | |
| K123387 | QUIKCLOT HEMOSTATIC DRESSING | QSY | Substantially Equivalent | |
| K120782 | INTERVENTIONAL HEMOSTATIC BANDAGE | QSY | Substantially Equivalent | |
| K090620 | QUIKCLOT INTEVENTIONAL, MODEL P/N 182 | QSY | Substantially Equivalent | |
| K080247 | QUIKCLOT NOSEBLEED | LYA | Substantially Equivalent | |
| K072474 | QUIKCLOT EX | QSY | Substantially Equivalent | |
| K070010 | QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER | QSY | Substantially Equivalent | |
| K061767 | QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+ | QSY | Substantially Equivalent | |
| K051955 | QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE | QSY | Substantially Equivalent | |
| K050769 | QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172 | QSY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004138549 | 3004138549 | Z-MEDICA, LLC | 4 FAIRFIELD BLVD., Wallingford, CT 06492 US | 2026 | |
| 3015437221 | 3015437221 | Z-MEDICA, LLC | 222 Universal Drive, North Haven, CT 06473 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0211-2022 | 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. | Class II | Terminated | |
| Z-0925-2018 | 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 wounds (operative, postoperative, dermatological, etc.) and traumatic injuries | 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). | Class II | Terminated | |
| Z-2612-2017 | 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 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 wounds (operative, postoperative, dermatological, etc.) and traumatic injuries | Packaging breach may compromise sterility | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain