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Z-Medica, LLC

US

Last updated September 17, 2026

Information

Country
US
Address
222 Universal Drive, North Haven, CT, 06473
Website
teleflex.com
LinkedIn
—
Facebook
—
Phone
877-750-0504
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3015437221
DUNS Number
079190073

Catalogue (61)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
QuikClot 0261
FDA UDI
UActive
QuikClot 0548
FDA UDI
UActive
QuikClot 0473
FDA UDI
UActive
QuikClot 0540
FDA UDI
UActive
QuikClot 0621
FDA UDI
UActive
QuikClot 0534
FDA UDI
UActive
QuikClot 0547
FDA UDI
UActive
QuikClot 0541
FDA UDI
UActive
QuikClot 0572
FDA UDI
UActive
QuikClot 0302
FDA UDI
UActive
QuikClot 0526
FDA UDI
UActive
QuikClot 0459
FDA UDI
UActive
QuikClot 0345
FDA UDI
UActive
QuikClot 0487
FDA UDI
UActive
QuikClot 0210
FDA UDI
UActive
QuikClot 0188
FDA UDI
UActive
QuikClot 467Z
FDA UDI
UActive
QuikClot 0289
FDA UDI
UActive
QuikClot 2010
FDA UDI
UActive
QuikClot 0301
FDA UDI
UActive
QuikClot 0538
FDA UDI
UActive
QuikClot 0613
FDA UDI
UActive
QuikClot 4030
FDA UDI
Class IIActive
QuikClot 0632
FDA UDI
UActive
QuikClot 0611
FDA UDI
UActive
QuikClot 4050
FDA UDI
Class IIActive
QuikClot 0633
FDA UDI
UActive
QuikClot 0475
FDA UDI
UActive
QuikClot 4020
FDA UDI
Class IIActive
QuikClot 0461
FDA UDI
UActive
QuikClot 0549
FDA UDI
UActive
QuikClot 4010
FDA UDI
Class IIActive
QuikClot 0458
FDA UDI
UActive
QuikClot 0510
FDA UDI
UActive
QuikClot 4000
FDA UDI
Class IIActive
QuikClot 0499
FDA UDI
UActive
QuikClot 0539
FDA UDI
UActive
QuikClot 0303
FDA UDI
UActive
QuikClot 0612
FDA UDI
UActive
QuikClot 0583
FDA UDI
UActive
QuikClot 0350
FDA UDI
UActive
QuikClot 0622
FDA UDI
UActive
QuikClot 0200
FDA UDI
UActive
QuikClot 0374
FDA UDI
UActive
QuikClot 0460
FDA UDI
UActive
QuikClot 0183
FDA UDI
UActive
QuikClot 0636
FDA UDI
UActive
Quickclot Acs - Accelerated Clotting Sponge K051955
FDA 510(k)
UActive
Quikclot Inteventional, Model P/N 182 K090620
FDA 510(k)
UActive
Interventional Hemostatic Bandage K120782
FDA 510(k)
UActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

DateRecall No.ClassStatusReason
Sep 22, 2021Z-0211-2022—terminated

Lack of Packaging seal integrity may result in a sterile barrier breach.

Nov 17, 2017Z-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, 2017Z-2612-2017—terminated

Packaging breach may compromise sterility