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 ·Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter

VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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 ·Interface CABLES, Navistar Electrophysiology Catheter, EZ Steer Nav Bi-Directional Electrophysiology Catheter, Navistar

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVISTAR Electrophysiology Catheter, EZ Steer NAV Bi-Directional Electrophysiology Catheter, NAVISTAR RMT Electrophysiol

Wet Essential95 Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MEDICAL GRADE SILICONE BLOCK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101

FDA 510(k)

FDA Class 2 ·Cardiovascular

OIC External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

TISMESH SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

FAQ™ (102)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME

FDA 510(k)

FDA Class 2 ·Orthopedic

ULTROID HEMORRHOID MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MATRIX MICROSON 410

FDA 510(k)

FDA Class 2 ·Physical Medicine

SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100

FDA 510(k)

FDA Class 2 ·Radiology

MICOR Lens Fragmentation System

FDA 510(k)

FDA Class 2 ·Ophthalmic

VEOLAR VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology