Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COLLASTAT INSTAT ABSORABLE COLLAGEN HOMESTATIC AGENTS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM STS SYSTEM

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Helistat Absorbable Collagen Hemostatic Agent and Helitene- Fibrillar Form

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm Injectable Gel Implants

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·Propel Sinus Implant, Propel Mini Sinus Implant, Propel Contour Sinus Implant

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STYLE 17 & 17A POSTERIOR CHAMBER IOLS

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·HELITAPE AND HELIPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvederm Injectable Gel Implants

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvederm Voluma XC, Juvederm Vollure XC, and Juvederm Volbella XC

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·TCI HEARTMATE VE LVAS

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·SALINE-FILLED BREAST IMPLANTS

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·GK-101E CARIES REMOVAL AGENT/SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Silicone-Filled Breast Implants