Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL SURESHOT ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL CONTROL ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL II ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL ARTERIAL CLOSURE SYSTEM WITH Q-FOAM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL SURESTAT ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL CONTROL FEMORAL ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL II ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·SURESTAT ARTERIAL CLOSURE 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

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Conformable GORE TAG Thoracic Endoprosthesis

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·Hydrus® Microstent

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FO

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM