Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTMATE XVE LVAS

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Exact Spinal Sealant System.

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

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

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFE VEST WEARABLE DEFIBRILLATOR

Device. Laser Peripheral Angioplasty

FDA Pre-Market Approval

FDA Class 3 ·TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE

Stent, Iliac

FDA Pre-Market Approval

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

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LifePulse High Frequency Ventilator

Device. Laser Peripheral Angioplasty

FDA Pre-Market Approval

FDA Class 3 ·TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Dural Sealant System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus XC

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Silicone-Filled Breast Implants

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm Injectable Gel Implants (Ultra, Ultra XC, Ultra Plus XC)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM VOLUMA XC

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Saline-Filled Breast Implants

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest® Wearable Defibrillator

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·ORCOLON (R) (POLYACRYLAMIDE)

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Saline-Filled Breast Implants

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·TCI HEARTMATE(R) 1000A IP LVAS