Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

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 ·RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR RESTORARION AND OR/ CORRECTION OF THE SIGNS OF FACIAL FAT LO

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR RESTORATION AND OR CORRECTION FOR THE SIGNS OF FACIAL FAT LO

Agent, Occluding, Vascular, Permanent

FDA Pre-Market Approval

FDA Class 3 ·VenaSeal Closure System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Algovita Spinal Cord Stimulation System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Relia IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT/FIDELIS/QUATTRO/SUBCUTANEOUS LEAD/SUB-Q DEFIBRILLAION LEAD/TRANSVENE CS/SVC LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT QUATTRO/QUATTRO SECURE/SUBCUTANEOUS LEAD/SUB-Q TUNNELING TOOL/TRANSVENE SVC LEAD

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter SPinal Cor

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Zoll R Series

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION, PRECISION SPECTRA, PRECISION NOVI, PRECISION MONTAGE, AND PRECISION MONTAGE MRI SCS SYSTEMS

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS,ILAC,VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM HYALURONATE