Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·G5 Mobile Continuous Glucose Monitoring Systems

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALNAT

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SALINE FILLED BREAST IMPLANT

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Gastric Emptying Breath Test

FDA Pre-Market Approval

FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR (MODELS 4000)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 Mobile Continuous Glucose Monitoring System

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·ND:YAG POSTERIOR CAPSULOTOMY MODEL 100

Device. Laser Peripheral Angioplasty

FDA Pre-Market Approval

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

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Exact SPine Sealant System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Diamondback 360 Precision Coronary Orbital Atherectomy System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 Mobile Continuous Glucose Monitoring System

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

FDA Pre-Market Approval

FDA Class 3 ·Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants