10,000 results · 37ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-MAK-2 PLUS ASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-MAK-2 PLUS ASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-MAK-2 PLUS ASSAY

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·DRG Small/Big Curve Delivery Sheath Kit, 22cm; DRG Lead Accessories Kit; SlimTip DRG Trial Lead Kit, 50cm and 90cm; Slim

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·EXCOR® Pediatric Ventricular Assist Device

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CapSureFix Lead

Ring, Endocapsular

FDA Pre-Market Approval
FDA Class 3 ·MORCHER® EYEJET® CTR Single-Use Injector

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CapSure Sense Lead, CapSure SP Novus Lead

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Myocardial Pacing Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CapSure Epicardial Pacing Lead

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Y Adapter/Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adapter, Sprint Quattro Lead, Subcutaneous Lead, Transven

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Transvene CS/SVC Lead

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·SelectSecure Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Epicardial Patch Lead

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

FDA Pre-Market Approval
FDA Class 3 ·DIASORIN ETI MAK-2 PLUS ASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·DIASORIN ETI-MAK-2 PLUS ASSAY

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTECEED Adhesion Barrier