Z-Medica, LLC

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
6
Inspections
7
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0211-2022Class IIQuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200September 22, 2021
Z-0925-2018Class IIQuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cutNovember 17, 2017
Z-2612-2017Class IIQuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 May 17, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K220971QuikClot Control+ Hemostatic DressingDecember 14, 2022
K200167QuikClot Control+April 23, 2020
K181641QuikClot RadialDecember 24, 2018
DEN160012D2 DressingJune 30, 2017
K140757D2 HEMOSTANTIC DRESSINGJuly 17, 2014
K123387QUIKCLOT HEMOSTATIC DRESSINGApril 12, 2013