Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·Wearable Defibrillator Life Vest

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Helistat® and Helitene® Absorbable Collagen Hemostatic Agents

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LifePulse High Frequency Ventilator

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

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 Voluma XC

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Silicone-Filled Breast Implants

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM STS SYSTEM

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm® Volbella™ XC

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS, JUVEDERN VOLUMA XC

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest® Wearable Defibrillator

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm Injectable Gel Implants

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS, HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENT FIBULLAR FORM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SEVEN SYSTEM