18 results · 39ms · Sources: EU EUDAMED, US FDA

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Aveir™ Leadless System (Dual-Chamber)

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Aveir™ Leadless System (Dual-Chamber)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Aveir™ Leadless System (Dual-Chamber)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Aveir™ Leadless System (Dual-Chamber)

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

FDA Pre-Market Approval
FDA Class 3 ·Aveir™ Leadless System (Dual-Chamber)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Aveir™ Leadless System (Dual-Chamber)

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval
FDA Class 3 ·GEM 21S GROWTH FACTOR ENHANCED MATRIX RHPDGF-BB COMPONENT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER

Manual Antimicrobial Susceptibility Test Systems

FDA Pre-Market Approval
FDA Class 2 ·UNISCEPT(TM)

Manual Antimicrobial Susceptibility Test Systems

FDA Pre-Market Approval
FDA Class 2 ·UNISCEPT(TM)

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·AIS EXIMER LASER ANGIOPLASTY

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MODEL 5348 SINGLE CHAMBER TEMPORARY PACEMAKER (AAI/VVI) AND MODEL 5388 DUAL CHAMBER TEMPORARY PACEMAKER