Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA classification

FDA Class 3 ·Implanted Diaphragmatic/Phrenic Nerve Stimulator

Micro-Condom

FDA classification

FDA Class 3 ·Micro-Condom

Rheoencephalograph

FDA classification

FDA Class 3 ·Rheoencephalograph

Analyzer, Data, Obstetric

FDA classification

FDA Class 3 ·Analyzer, Data, Obstetric

System, Abortion, Metreurynter-Balloon

FDA classification

FDA Class 3 ·System, Abortion, Metreurynter-Balloon

Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal

FDA classification

FDA Class 3 ·Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal

Prosthesis, Breast, Inflatable, Internal, Saline

FDA classification

FDA Class 3 ·Prosthesis, Breast, Inflatable, Internal, Saline

Prosthesis, Finger, Constrained, Metal, Uncemented

FDA classification

FDA Class 3 ·Prosthesis, Finger, Constrained, Metal, Uncemented

Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation

FDA classification

FDA Class 3 ·Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation

Metallic Cemented Glenoid Hemi-Shoulder Prosthesis

FDA classification

FDA Class 3 ·Metallic Cemented Glenoid Hemi-Shoulder Prosthesis

Stimulator, Intracerebral/Subcortical, Implanted

FDA classification

FDA Class 3 ·Stimulator, Intracerebral/Subcortical, Implanted

Electrode, Clip, Fetal Scalp (And Applicator)

FDA classification

FDA Class 3 ·Electrode, Clip, Fetal Scalp (And Applicator)

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

FDA classification

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM SHARE SYSTEM

Joint, Temporomandibular, Implant

FDA classification

FDA Class 3 ·Joint, Temporomandibular, Implant

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·PerClot Polysaccharide Hemostatic System

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE (LN 6L22)

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·Optiguide Cylindrical Fiber Optic

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB, Alinity i Anti-HBs

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS