Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm Injectable Gel Implants

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm® Hyaluronate Gel Implants

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Dexcom G4 Platinum/G5 Mobile Continuous Glucose Monitoring System

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Dural Sealant System

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN & SEVEN PLUS SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CYROABLATION THERAPY SYSTEM

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE(TM)

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER

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

FDA Pre-Market Approval

FDA Class 3 ·VISULAS ND:YAG LASER

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COLLASTAT

Device. Laser Peripheral Angioplasty

FDA Pre-Market Approval

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

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·G5 Mobile Continuous Glucose Monitoring System

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)

Gastric Emptying Breath Test

FDA Pre-Market Approval

FDA Class 3 ·13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)