Medical Device Manufacturer · US , Wallingford , CT

Z-Medica, LLC - FDA 510(k) Cleared Devices

6 submissions · 5 cleared · Since 2013

Recent clearances: QuikClot Control+ Hemostatic Dressing, QuikClot Control+, QuikClot Radial

6
Total
5
Cleared
1
Denied

FDA 510(k) Regulatory Record - Z-Medica, LLC General & Plastic Surgery ✕

6 devices
1-6 of 6
Cleared Dec 14, 2022
QuikClot Control+ Hemostatic Dressing
K220971 · POD
General & Plastic Surgery · 254d
Cleared Apr 23, 2020
QuikClot Control+
K200167 · POD
General & Plastic Surgery · 91d
Cleared Dec 24, 2018
QuikClot Radial
K181641 · QSY
General & Plastic Surgery · 186d
Not Cleared Jun 30, 2017
D2 Dressing
DEN160012 · POD
General & Plastic Surgery · 471d
Cleared Jul 17, 2014
D2 HEMOSTANTIC DRESSING
K140757 · QSY
General & Plastic Surgery · 113d
Cleared Apr 12, 2013
QUIKCLOT HEMOSTATIC DRESSING
K123387 · QSY
General & Plastic Surgery · 161d
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