EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License

FDA 510(k)

FDA Class 2 ·Cardiovascular

CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

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

ELCAM STOPCOCKS AND MANIFOLDS

FDA 510(k)

FDA Class 2 ·General Hospital

HASKAL TORQUE DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

Analyzer, Medical Image

FDA classification

FDA Class 2 ·Analyzer, Medical Image

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

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

KENS INTERNAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SILICONE ENDOTRACHEAL TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPERMICIDAL LUBRICATED MALE LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GLOVES, PATIENT EXAMINATION

FDA 510(k)

FDA Class 2 ·Microbiology

SILICATH ALL SILICONE FOLEY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology