MR DWI/FLAIR Measurement V1.0

FDA 510(k)

FDA Class 2 ·Radiology

Olea S.I.A. Neurovascular V1.0

FDA 510(k)

FDA Class 2 ·Radiology

Olea Sphere V3.0

FDA 510(k)

FDA Class 2 ·Radiology

Implantswiss Dental Implant System and Implantswiss Dental Abutment System

FDA 510(k)

FDA Class 2 ·Dental

CINA

FDA 510(k)

FDA Class 2 ·Radiology

MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·STOCKERT 70 RF GENERATOR AND ACCESSORIES/INTERFACE CABLE

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVISTAR RMT; NAVISTAR RMT DS CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter, and Biosense Webster Cables

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Navistar EP, EZ Steer Nav Bi-Directional

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter,

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS AND CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Navistar Electrophysiology Catheter

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER\

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CORDIS WEBSTER DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NaviStar Catheter, NaviStar RMT Catheter, EZ Steer Nav Catheter, Interface Cables

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·nMARQ Catheter Interference Cable