10,000 results · 144ms · Sources: EU EUDAMED, US FDA

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System (Shockwave IVL System) with Shockwave C2 and C2+ IVL Catheters

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

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

FDA Pre-Market Approval
FDA Class 3 ·ANIMAS VIBE SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

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

FDA Pre-Market Approval
FDA Class 3 ·ANIMAS VIBE SYSTEM

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DuraSeal Dural Sealant System

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DURASEAL EXACT SPINE SEALANT SYSTEM

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus ET Autospray Dural Sealant

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DuraSeal Dural Sealant System

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·ADHERUS AUTOSPRAY DURAL SEALANT

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DuraSeal Dural Sealant System

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DURASEAL EXACT SPINE SEALANT SYSTEM

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DuraSeal Exact Spine Sealant System

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·CraniSeal Dural Sealant

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus ET AutoSpray Dural Sealant