467 results · 30ms · Sources: EU EUDAMED, US FDA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·QUANTITOPE 125I AFP KIT AND CONTROL SERUM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·QUANTITOPE 125I AFP KIT AND CONTROL SERUM

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

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

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

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

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

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

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

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

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

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

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

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·ISPAN TM SULFUR HEXAFLUORIDE (SF6) GAS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Proclaim SCS IPG

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Infinity DBS IPG

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Bellafill Dermal Filter

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Proclaim DRG IPG

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·STARCLOSE VASCULAR CLOSURE SYSTEM

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·RIGID GAS PERMEABLE CONTACT LENSES (BOSTON ORTHOKERATOLOGY)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE G AND SG ENDOCARDIAL DEFIBRILLATION LEAD