Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL VSA02/VSC02 V9.0 PROGRAMMING SOFTWARE FOR THE DIVA, DEMA, AND SELECTION AFM MODEL 902 PULSE GENERATORS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DEMA, DIVA AND AFM PULSE GENERATORS

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject® W Trabecular Micro-Bypass System

Tympanostomy Tube Delivery Product With Drug

FDA Pre-Market Approval

FDA Class 3 ·Tula SystemTube Delivery System (TDS)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PROVIT MODEL VSA02 VERSION 6.1 SOFTWARE BUILD 63 SERVICE RELEASE FOR DEMA, DIVA AND SELECTION AFM FAMILIES OF PULSE GENS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DIVA PACING SYSTEM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject® W Trabecular Micro-Bypass System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM CGM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·IPRO2 CGM RECORDER

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·iPro2 CGM System

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense E3 CGM System

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·IPRO2 CGM SYSTEM WITH ENLITE SENSOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·iPro2 CGM System with Enlite Sensor

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·iPro2 CGM System with Enlite Sensor