Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WCD 3000 SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Silicone-Filled Breast Implants

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

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

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 5BUV20-24DO IOL

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE

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)

Sealant, Polymerizing

FDA Pre-Market Approval

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

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Progel Pleural Air Leak Sealant

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM VOLBELLA XC

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)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM STS CONTINOUS MONITORS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS

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 and G5 Mobile Continuous Glucose Monitoring Systems

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Neuspera Sacral Neuromodulation System