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Z-Medica Corporation

USA · Wallingford

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 1Class II 1Class III 0unclassified 1

plus 18 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

7active device licences

Class II 7

11 including historic records

TWTaiwanTFDA

3valid device licences

Class I 1Class II 2

SGSingaporeHSA SMDR

5device registrations

CLASS C 5

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

Class III 1IIb 1

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States18 registration records, 14 510(k), 0 PMA, 50 excluded

Brazil0 confirmed, 42 excluded

Saudi Arabia0 confirmed, 7 excluded

Canada7 confirmed, 12 excluded

Manufacturer names merged into this page: Z-MEDICA, LLC · Z-MEDICA CORPORATION · Z-MEDICA

FDA 510(k) clearances by year

22005

12006

22007

12008

12009

22013

12014

12017

12018

12020

12022

FDA listed device types

Temporary, Internal Use Hemostatic 1Hemostatic Wound Dressing Without Thrombin Or Other Biologics 1Gauze / Sponge,Nonresorbable For External Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220971	QuikClot Control+ Hemostatic Dressing	2022-12-14
US	K200167	QuikClot Control+	2020-04-23
US	K181641	QuikClot Radial	2018-12-24
CA	66035	QUIKCLOT HEMOSTATIC AGENT	Class II
CA	79620	QUIKCLOT HEMOSTATIC DRESSING	Class II
CA	84825	QUIKCLOT HEMOSTATIC GAUZE SPONGE (ANTICOAGULATED PATIENTS)	Class II