94 results · 41ms · Sources: EU EUDAMED, US FDA

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE Silicone-Filled Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS.

Hepatitis Delta Serological Reagents

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT ANTI-DELTA (EIA) ASSAY

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS

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

FDA Pre-Market Approval
FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC EIA

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·HAVAB-M (R) EIA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT AFP-EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-EIA

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·HAVAB-M EIA

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval
FDA Class 3 ·ER-EIA MONOCLONAL

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval
FDA Class 3 ·PGR-EIA MONOCLONAL

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-EIA

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·HAVAB (R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-EIA

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·MYNXGRIP Vascular Closure Device, MYNX CONTROL Vascular Closure Device

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

FDA Pre-Market Approval
FDA Class 3 ·MONOLISA ANTI-HBS EIA

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT PGR-EIA MONOCLONAL

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-EIA KIT

Hepatitis Delta Serological Reagents

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT ANTI-DELTA EIA