System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces Specify and Vectris Spinal Cord S

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System Ascenda Intrathecal Catheters

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System. Verify Evaluation System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System / Ascenda Intrathecal Catheters

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3 (HM3) Left Ventricular Assist System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ (HM3) Left Ventricular Assist System

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARIDEX(TM) REMOVAL SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARIDEX(TM) REMOVAL SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARISOLV MINIMAL INVASIVE DENTAL CARIES REMOVAL SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·GK-101E CARIES REMOVAL AGENT/SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·GK-101E CARIES REMOVAL AGENT/SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3 Left Ventricular Assist System (HM3 LVAS)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ (HM3) Left Ventricular Assist System (LVAS)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)