4,936 results · 54ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·On- X Prosthetic Heart Valve, Ascending Aortic Prothesis

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Oncomine Dx Target Test

LIFESTYLE BREAK THRU (POLYMACON)

FDA 510(k)
FDA Class 2 ·Ophthalmic

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

DBS-ADX

Basic UDI-DI
EU MDR · Eu Md Class 2a ·12 devices

CDX-100

Basic UDI-DI
EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device

CDX-100

Basic UDI-DI
EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device

CDX-70

Basic UDI-DI
EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device

CDX-70

Basic UDI-DI
EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device

CDX-60

Basic UDI-DI
EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device

CDX-60

Basic UDI-DI
EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device

CDX-40

Basic UDI-DI
EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device

CDX-40

Basic UDI-DI
EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device

CDX-40

Basic UDI-DI
EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device

CDX-170

Basic UDI-DI
EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device

CDX-160

Basic UDI-DI
EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device

CDX-170

Basic UDI-DI
EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device