9,613 results · 43ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·CARBOMEDICS/CARBO-SEAL ASCENDING & VALSALVA/ORBIS/OPTIFORM HEART VALVES

Calibration Gas Mixture, Lung Diffusion Test Mixture, Clinical Blood Gas Mixture

FDA registration
NEXAIR, LLC·1 product·🇺🇸 United States

Aquilo Sports CT1000

FDA registration
AQUILO SPORTS L.L.C.·1 product·🇺🇸 United States

Laser Gas Mixture

FDA registration
NEXAIR, LLC·1 product·🇺🇸 United States

Laser Gas Mixture

FDA registration
NEXAIR, LLC.·1 product·🇺🇸 United States

Calibration Gas Mixture, Lung Diffusion Test Mixture, Clinical Blood Gas Mixture

FDA registration
NEXAIR, LLC.·1 product·🇺🇸 United States

Aquilo Sports CCT1500 System

FDA registration
AQUILO SPORTS L.L.C.·1 product·🇺🇸 United States

Factor II Deficient Substrate Plasma

FDA UDI
HELENA LABORATORIES CORPORATION·M52551900·

Lyophilized Platelets

FDA UDI
TCOAG IRELAND LIMITED·05391521420091·

Asserachrom® IX:Ag

FDA UDI
DIAGNOSTICA STAGO·03607450009439·

STA® - Staclot® Protein C 1

FDA UDI
DIAGNOSTICA STAGO·03607450007473·

CRYOcheck™ Clot C™

FDA UDI
Precision Biologic Inc·00843876000404·

Coatest SP FVIII

FDA UDI
INSTRUMENTATION LABORATORY COMPANY·08426950453000·Coatest SP FVIII

VisuLize Factor FIX Antigen Kit

FDA UDI
Affinity Biologicals Inc·10629009020009·96 Test enzyme immunoassay kit for the determin...

HemosIL ProClot Diluent

FDA UDI
INSTRUMENTATION LABORATORY COMPANY·08426950043966·HemosIL ProClot Diluent 100 mL

Chrono-log

FDA UDI
CHRONO-LOG CORP·00811476010130·Tris Buffered Saline

CRYOcheck Chromogenic Factor IX

FDA UDI
Precision Biologic Inc·00843876000565·CRYOcheck Chromogenic Factor IX is for clinical...

BIOPHEN Protein C 2.5

FDA UDI
HYPHEN BIOMED·03663537008221·

Helena Ristocetin - 10 mg/mL

FDA UDI
HELENA LABORATORIES CORPORATION·M52553720·

HemosIL Protein C

FDA UDI
INSTRUMENTATION LABORATORY COMPANY·08426950438670·HemosIL Protein C