32 results · 18ms · Sources: EU EUDAMED, US FDA

Reherniation Reduction Device

FDA Pre-Market Approval
FDA Class 3 ·Barricaid Anular Closure Device (ACD)

Reherniation Reduction Device

FDA Pre-Market Approval
FDA Class 3 ·Barricaid® Annular Closure Device - Model Number BAR-A8-8MM (2730815-A&), Barricaid® Annular Closure Device - Model Numb

Reherniation Reduction Device

FDA Pre-Market Approval
FDA Class 3 ·BARRICAID ANULAR CLOSURE DEVICE (ACD)

Reherniation Reduction Device

FDA Pre-Market Approval
FDA Class 3 ·Barricaid Annular Closure Device

Reherniation Reduction Device

FDA Pre-Market Approval
FDA Class 3 ·Barricaid Anular Closure Device

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Genesis Neurostimulation System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE 4-SITE Leads

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·Animas Vibe System

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

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Philips HeartStart FR3 Defibrillator

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

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS

Stimulator, Bone Growth, Non-Invasive

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