1,670 results · 21ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·LIAISON® XL MUREX Anti-HBe assay and Control

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

FDA Pre-Market Approval
FDA Class 3 ·LIAISON® XL MUREX HBsAg Qual assay and Control

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·LIAISON® QuantiFERON TB-Gold Plus assay and Control

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

FDA Pre-Market Approval
FDA Class 3 ·LIAISON® XL MUREX Anti-HBs assay, Control and Verifiers

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·FINELINE II STEROX LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACUITY SPIRAL LEAD FAMILY

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·ARTEGRAFT COLLAGEN VASCULAR GRAFT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·Artegraft Collagen Vascular Graft

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·Artegraft Collagen Vascular Graft

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·N.C.G.T. GRAFT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·SURGIKOS ARTIGRAFT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·ARTEGRAFT COLLAGEN VASCULAR GRAFT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·BIOPOLYMERIC(TM) VASCULAR GRAFT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·N.C.G.T. GRAFT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·N.C.G.T. GRAFT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·ARTEGRAFT COLLAGEN VASCULAR GRAFT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·N.C.G.T. GRAFT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·Artegraft Collagen Vascular Graft

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·Artegraft Collagen Vascular Graft