Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra System

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra System

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra System

Diazyme Procalcitonin (PCT) Assay

FDA registration

Diazyme Laboratories, Inc.·1 product·🇺🇸 United States

Access PCT (P/N: C53987)

FDA registration

BECKMAN COULTER, INC.·1 product·🇺🇸 United States

Access PCT (P/N: C53987)

FDA registration

BECKMAN COULTER, INC.·1 product·🇺🇸 United States

STANBIO LABORATORY

FDA registration

STANBIO LABORATORY·1 product·🇺🇸 United States

JOTEC GmbH

Authorized representative

🇩🇪 Germany·2 Manufacturers

Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece

FDA 510(k)

FDA Class 1 ·Dental

URODYNAMIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OXYGEN CONSUMPTION MONITOR #OCM-0100

FDA 510(k)

FDA Class 2 ·Cardiovascular

CDI OneView Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

GOLD GATORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300

FDA 510(k)

FDA Class 2 ·Cardiovascular

UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ETUDE, URODYNAMIC INVESTIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STAT-SAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

1512M/F WIRE ELECTRODE NEEDLE SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOTEK ULTRA SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEMATOCRIT-SATURATION MONITOR HSM-100

FDA 510(k)

FDA Class 2 ·Cardiovascular