Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)

FDA 510(k)

FDA Class 2 ·Radiology

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS, MODEL D-1249-02-S

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG

FDA 510(k)

FDA Class 2 ·Anesthesiology

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER

Catheter, Intracardiac Mapping, High-Density Array

FDA classification

FDA Class 2 ·Catheter, Intracardiac Mapping, High-Density Array

Catheter, Intracardiac Mapping, High-Density, Reprocessed

FDA classification

FDA Class 2 ·Catheter, Intracardiac Mapping, High-Density, Reprocessed

Radioimmunoassay, Amphetamine

FDA classification

FDA Class 2 ·Radioimmunoassay, Amphetamine

Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode

FDA 510(k)

FDA Class 2 ·Neurology

Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)

FDA 510(k)

FDA Class 2 ·Radiology

NIRO-200NX

FDA 510(k)

FDA Class 2 ·Cardiovascular

P300 Attachment

FDA 510(k)

FDA Class 2 ·Neurology

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5

FDA 510(k)

FDA Class 2 ·Radiology

Estelite Universal Flow

FDA 510(k)

FDA Class 2 ·Dental

FUJIFILM Endoscope Model EG-530N

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XIDF-AWS801, Angio Workstation, V7.0

FDA 510(k)

FDA Class 2 ·Radiology

Image Filing Software NAVIS-EX

FDA 510(k)

FDA Class 2 ·Radiology

Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0

FDA 510(k)

FDA Class 2 ·Radiology

EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology