Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR-T PULSE GENERATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PHILOS II DR, PHILOS II D, PHILOS II DR-T, PHILOS II SLR, PHILOS II SR, PHILOS II S, AND PROGRAMMER SOFTWARE VERSION A-U

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

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·HOME MONITORING SYSTEM

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Neuroform Atlas® Stent System

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity™ HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity HPV Assay

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon System with Navigation and Touch

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·OBALON BALLOON SYSTEM