4,774 results · 21ms · Sources: EU EUDAMED, US FDA

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE FIREFLY (ADULT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE FIREFLY (PEDIATRIC)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

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

FDA Pre-Market Approval
FDA Class 3 ·Atellica IM Hepatitis B e Antigen (HBeAg)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

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

FDA Pre-Market Approval
FDA Class 3 ·Atellica IM HBc Total 2 (HBcT2)

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

FDA Pre-Market Approval
FDA Class 3 ·Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2); Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control (

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

FDA Pre-Market Approval
FDA Class 3 ·R3™ Delta Ceramic Acetabular System

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM STERILE BLISTERS WITH INTERNAL ANTIBLOCK

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COMBI 40+COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COMBI 40 + COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COMBI 40+ COHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL Cochlear Implant System

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEM