Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·SMART NITINOL SYSTEM & SMART CONTROL NITINOL STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Carotid Wallstent Monorail Endoprosthesis

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·RxSight Light Adjustable Lens (LAL) and light Delivery Device (LDD)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed iPro2 CGM System with Enlite Sensor

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP; PARADIGM REAL-TIME REVEL INSULIN PUMP

Stent, Urethral, Prostatic, Permanent Or Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·UROLUME(TM)ENDOPROSTHESIS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Evoke® SCS System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 3 IS-1 LEADS

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed 630G System

Stent, Coronary

FDA Pre-Market Approval

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

Stent, Central Venous

FDA Pre-Market Approval

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

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·OXFORD PATIAL KNEE SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed Paradigm Real-Time Revel System

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ActaStim-S Spine Fusion Stimulator

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR URINARY CONTROL

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

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