105 results · 22ms · Sources: EU EUDAMED, US FDA

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM

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

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

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

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

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

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

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·THE AMPLATZER SEPTAL OCCLUDER DEVICE

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·BIO OSTEOGEN SYSTEM

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·S.M.A.R.T NITINOL STENT SYSTEM & CONTROL NITINOL STENT SYSTEM

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

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·BIO OSTEOGEN SYSTEM 204

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·BIO OSTEOGEN SYSTEM 204

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·BIO OSTEOGEN SYSTEM 204

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·BIO OSTEOGEN SYSTEM 204

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·BIO OSTEOGEN SYSTEM 204

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·BIO OSTEOGEN SYSTEM 204

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·BIO OSTEOGEN SYSTEM 204

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Inspire Model 2740 Programmer

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Septal Occluder (ASO/ASD)

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM