182 results · 19ms · Sources: EU EUDAMED, US FDA

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus® Auditory Brainstem Implant

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus AB1541 Auditory Brainstem Implant

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS AUDITORY BRAINSTEM IMPLANT

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus ABI541 Auditory Brainstem Implant System

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS AUDITORY BRAINSTEM IMPLANT

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus Auditory Brainstem Implant System

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus Auditory Brainstem Implant System

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus Auditory Brainstem Implant System

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus Auditory Brainstem Implant

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Auditory Brainstem Implant

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

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS

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

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx®

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval
FDA Class 3 ·ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AFP RIA KIT

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval
FDA Class 3 ·Alere NMP22 BladderChek Test

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval
FDA Class 3 ·Alere NMP22 BladderChek Test