2,194 results · 39ms · Sources: EU EUDAMED, US FDA

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SYNCARDIA COMPANION 2 DRIVER SYSTEM

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·Syncardia Temporary Cardio West Total Artificial Heart (TAH-T)

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Maris Care Slip met Plakstrip Super M

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Maris Care BV·1 device

Maris Care Slip met Plakstrip Super L

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Maris Care BV·1 device

Sterigenics Belgium Fleurus SA

FDA registration
Sterigenics Belgium Fleurus SA·4 products·🇧🇪 Belgium

Tutopatch® Bovine Pericardium

FDA registration
Sterigenics Belgium Fleurus SA·4 products·🇧🇪 Belgium

Tutomesh® Bovine Pericardium

FDA registration
Tutogen Medical GmBH·4 products·🇩🇪 Germany

TutoMesh, TutoPatch

FDA registration
BBF STERILISATIONSSERVICE GMBH·4 products·🇩🇪 Germany

Tutomesh® Bovine Pericardium

FDA registration
RTI Surgical, Inc. (dba RTI Biologics, Inc.)·4 products·🇺🇸 United States

CopiOs Paricardium Membrane

FDA registration
BBF STERILISATIONSSERVICE GMBH·4 products·🇩🇪 Germany

Tutopatch® Bovine Pericardium

FDA registration
Tutogen Medical GmBH·4 products·🇩🇪 Germany

Premofix easy L XL

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Andanza International, Inh. Ulrich Östreicher e.K.·1 device

DT-L-725;DT-L-726;DT-L-727;DT-L-728;DT-L-729;DT-L-730;DT-L-731;DT-W-622;DT-Z-612;DT-Z-613;DT-Z-614;DT-Z-615;

FDA registration
BEIJING BOHAIKANGYUAN MEDICAL DEVICES CO.,LTD.·1 product·🇨🇳 China

ALCOHOL PREP AND POVIDONE-IODINE PREP

FDA 510(k)
FDA Unclassified ·Unknown

ANTIFOG

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

S,M,L,XL,Customized

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Xiantao Dawill Protective Products. Co.,Ltd.·1 device

Arm sling, size L/XL

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Medtex Swiss Ltd·1 device

Punch, Gelfoam, Non-Sterile

FDA classification
FDA Class 1 ·Punch, Gelfoam, Non-Sterile