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

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)

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·OPTIGUIDE(TM) FIBER OPTIC DIFFUSER

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·OPTIGUIDE Fiber Optic Diffuser (pb 200, PB 700 Series)

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·OPTIGUIDE CYLINDRICAL FIBER OPTIC(DCYL2 DIFFUSER SERIES)

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

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

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·OPTIGUIDE PHOTODYNAMIC THERAPY FIBER OPTIC TREATMENT 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 C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·OPTIGUIDE Cylindrical Fiber Optic

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·OPTIGUIDE CYLINDRICAL FIBER OPTIC

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

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

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

SILGEL STC-S

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GLOBAL MEDICAL CUTTING BIOPSY NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology