FDA Pre-Market Approval

DYNAGEN CRT-D, DYNAGEN X4 CRT-D,INOGEN CRT-D, INOGEN X4 CRT-D,ORIGEN CRT-D, ORIGEN X4 CRT-D, INCEPTA TM ICD,ENERGEN TM I

CMI s.r.o.

Importer

🇨🇿 Czechia·3 Manufacturers

GPI S.P.A.

Manufacturer

🇮🇹 Italy·7 Basic UDI-DIs·7 Devices·ITALCERT SRL, BUREAU VERITAS ITALIA S.P.A., and BUREAU VERITAS ITALIA S.P.A.

NTC Srl

Manufacturer

🇮🇹 Italy·ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

Euleria srl Società Benefit

Manufacturer

🇮🇹 Italy·BUREAU VERITAS ITALIA S.P.A., BUREAU VERITAS ITALIA S.P.A., and BUREAU VERITAS ITALIA S.P.A.

FREY SPÓŁKA JAWNA

Manufacturer

🇵🇱 Poland·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

UV Smart Technologies B.V.

Manufacturer

🇳🇱 Netherlands·3 Basic UDI-DIs·3 Devices·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and UDEM Adriatic d.o.o.

UZUMCU HOSPITAL EQUIPMENT METAL PROCESSING INDUSTRY AND TRADE COMPANY

Manufacturer

🇹🇷 Türkiye·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and UDEM Adriatic d.o.o.

Omnifix™

FDA UDI

B. BRAUN MEDICAL INC.·04046963451936·20 mL LL 21 Ga. x 1-1/2 in.

CareTouch

FDA UDI

WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.·06975442098110·Hypodermic Needles

Sterile Single-use Syringe with Needle

FDA UDI

Jiangxi Hongda Medical Equipment Group Ltd.·06920756729076·

Yeso med

FDA UDI

WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.·06971352284353·Piston syringe luer slip with needle

Yeso med

FDA UDI

WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.·06971352282229·Piston syringe luer slip without needle

Yeso med

FDA UDI

WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.·06971352283899·Piston syringe with needle

Yeso med

FDA UDI

WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.·06971352282373·Piston syringe luer slip with needle

LiteTouch

FDA UDI

AMITY HOLDINGS, LLC·00732671072320·MediCore's LiteTouch Brand Luer Lock Hypodermic...

Nipro Syringe

FDA UDI

NIPRO MEDICAL CORPORATION·00383790007184·3mL Luer Lock with attached needle 22G x 1"

Monoject

FDA UDI

Cardinal Health 200, LLC·10192253063271·Tuberculin Safety Syringe with Needle

Sterile Single-use Syringe with Needle

FDA UDI

Jiangxi Hongda Medical Equipment Group Ltd.·06920756729229·

SHINA

FDA UDI

Shina Corporation·08800117122310·LDS SYRINGES, 3.0cc, 23g x 1"