Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LIFE PULSE HIGH FREQUENCY JET VENTILATOR

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LIFE PULSE HIGH FREQUENCY JET VENTILATOR

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Avitene™ Microfibrillar Collagen Hemostat

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Avitene™ Microfibrillar Collagen Hemostat

Occluder, Balloon, Vena-Cava

FDA Pre-Market Approval

FDA Class 3 ·HUNTER-SESSIONS VENA-CAVA OCCLUDER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello T 53, Siello T 60, Siello JT 45, Siello JT 53, Solia T 53, Solia T 60, Solia JT 45, Solia JT 53, Siello S 45, Sie

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·ROCHE COBAS 4800 BRAF V600 MUTATION TEST

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SELOX ST/JT, SETROX S & DEXTRUS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Tupoa LV/ATX & Kronos LV-T / CRT-D & Corox OWT Steroid LV Pacing Lead

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Tupos LV/ATX & Kronos LV-T CRT-D and Corox OWT Steroid LV Pacing Lead