2,683 results · 29ms · Sources: EU EUDAMED, US FDA

Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

FDA Pre-Market Approval
FDA Class 3 ·remede® System

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·FlexAbility and FlexAbility SE Ablation Catheter

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System; FreeStyle Libre 14 Day Flash Glucose Monitoring System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF (GRAFTSKIN)

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·PyloPlus UBT System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·ISOMED IMPLANTABLE INFUSION PUMP

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval
FDA Class 3 ·Nucleus Hybrid L24 Implant System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus Cochlear Implant System

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·Floseal Hemostatic Matrix

Implant, Auditory Brainstem

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Biofinity XR Toric (comfilcon A)

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·TARGIS SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT AXSYM AFP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·SPINAL-STIM(R) MODEL 8212C

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Relay Thoracic Stent-Graft With Plus Delivery System

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1 (SP263) Assay