Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN PULSE GENERATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS PULSE GENERATORS - MODELS N118 & N119

Artificial Iris

FDA Pre-Market Approval

FDA Class 3 ·CustomFlex Artificial Iris

Artificial Iris

FDA Pre-Market Approval

FDA Class 3 ·CustomFlex ArtificialIris

Artificial Iris

FDA Pre-Market Approval

FDA Class 3 ·CustomFlex Artificial Iris

Artificial Iris

FDA Pre-Market Approval

FDA Class 3 ·CustomFlex Artificial Iris

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Aurora EV-ICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT VR ICD; M

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava CRT-D; Brava Quad CRT-D; Brava Quad CRT-D; Claria MRI CRT-D;

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·IBI THERAPY ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·IBI CARDIAC ABLATION SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Syncra CRT-P, Viva CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·IBI THERAPY CARDIAC ABLATION SYSTEM

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof ReStor +2.5 D Multifocal Intraocular lens /Toric Intraocular Lens/3.0 D Multifocal Toric Intraocular Lenses/ Tor