68 results · 19ms · Sources: EU EUDAMED, US FDA

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RESTYLANE INJECTABLE GEL

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+ C & T SERIES IPGS

System, Oxygen, Aqueous

FDA Pre-Market Approval
FDA Class 3 ·TherOx® DownStream® Cartridge (DSC-2)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DA+ C-SERIES AND DA+ T-SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DA+ C-SERIES & DA+ T-SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DA+C SERIES & DA+T SERIES

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE (VAD)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+C-SERIES/VITATRON DA+T SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA + C-SERIESAND VITATRON DA + T-SERIES

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-AB-AUK PLUS Assay

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-EBK PLUS Assay

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY DR & DC; ENTITY DR & DC

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+C & VITATRON DA+T SERIES IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+C & VITATRON DA+T SERIES IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+C & VITATRON DA+T SERIES IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+C & VITATRON DA+T SERIES IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+C & VITATRON DA+T SERIES IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+C & VITATRON DA+T SERIES IPGS