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

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave Medical, Inc. IVL Generator and Connector Cable Kit, Shockwave C2 Coronary IVL Catheter

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Cathete

Embolization Agent, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave C2 Intravascular (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)

Embolization Agent, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Lava Liquid Embolic System (Lava LES)

Embolization Agent, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators

Embolization Agent, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Lava Liquid Embolic System (Lava LES)

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 C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac

Embolization Agent, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Lava Liquid Embolic System (Lava LES)

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

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON EDGE AND TECNIS FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A