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

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

FDA Pre-Market Approval
FDA Class 3 ·MEMORYGEl BREAST IMPLANTS

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

FDA Pre-Market Approval
FDA Class 3 ·MENTOR MEMORYSHAPE BREAST IMPLANTS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MODEL 5038 CAPSURE VDD-2 LEAD

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

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (r

Shockwave Intravascular Lithotripsy System

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

Shockwave Intravascular Lithotripsy System

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

Stent Graft, Bypass, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·DETOUR System

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter

Solution, Removal, Carries

FDA Pre-Market Approval
FDA Class 3 ·CARIDEX(TM) REMOVAL SYSTEM

Shockwave Intravascular Lithotripsy System

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

Shockwave Intravascular Lithotripsy System

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

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter

Solution, Removal, Carries

FDA Pre-Market Approval
FDA Class 3 ·CARISOLV MINIMAL INVASIVE DENTAL CARIES REMOVAL SYSTEM

Stent Graft, Bypass, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·DETOUR 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

Shockwave Intravascular Lithotripsy System

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

Shockwave Intravascular Lithotripsy System

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