500 results · 67ms · Sources: EU EUDAMED, US FDA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT AUSAB

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·STARCLOSE SE VASCULAR CLOSURE SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT AUSAB

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE DEVICE

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK VISION CORONARY STENT SYSTEM AND MULTI-LINK MINI VISION CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·RX HERCULINK ELITE RENAL STENT SYSTEM

Total Bilirubin2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Albumin BCP2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Creatinine2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Albumin BCG2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Alkaline Phosphatase2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Urea Nitrogen2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Cholesterol2

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Amylase2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·Multi-Link 8 Coronary Stent System

Abbott FreeGo Enteral Feeding Pump

Basic UDI-DI
EU MDR · Eu Md Class 2a ·Zevex Inc.·1 device

Enteral Accessories

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Zevex Inc.·5 devices

Enteral Accessories

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Zevex Inc.·3 devices

Abbott Ireland

Authorized representative
🇮🇪 Ireland·1 Manufacturer·9 Devices