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

Prosthesis, Penis, Inflatable

FDA classification
FDA Class 3 ·Prosthesis, Penis, Inflatable

Mandibular Condyle Prosthesis

FDA classification
FDA Class 3 ·Mandibular Condyle Prosthesis

Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat

FDA classification
FDA Class 3 ·Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat

Stimulator, Neuromuscular, Implanted

FDA classification
FDA Class 3 ·Stimulator, Neuromuscular, Implanted

Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use

FDA classification
FDA Class 3 ·Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA classification
FDA Class 3 ·Implanted Diaphragmatic/Phrenic Nerve Stimulator

Stimulator, Intracerebral/Subcortical, Implanted

FDA classification
FDA Class 3 ·Stimulator, Intracerebral/Subcortical, Implanted

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

FDA classification
FDA Class 3 ·Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

Joint, Temporomandibular, Implant

FDA classification
FDA Class 3 ·Joint, Temporomandibular, Implant

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

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented

FDA classification
FDA Class 3 ·Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·ROCHE ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFORMATORY TEST AND PRECICONTROL HBSAG

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

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR

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

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

FDA classification
FDA Class 3 ·Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight

FDA classification
FDA Class 3 ·Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight