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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest Wearable Defibrillator

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·Propel Family of Sinus Implants

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Tridyne Vascular Sealent

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

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

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·TRIDYNE VASCULAR SEALANT; TRIDYNE VS Standard Spray Tips; TRIDYNE VS 6 Extended Spray Tip

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

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

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo

Fluid, Hysteroscopy

FDA Pre-Market Approval

FDA Class 3 ·HYSKON (32% DEXTRAN 70)

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·iCast Covered Stent System

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent- Microfibrillar Form

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Skinvive™ by Juvéderm®

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest® Wearable Defibrillator

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Dexcom G5 Platinum Contiuous Glucose Monitoring System