ATLANTIS GUI

FDA 510(k)

FDA Class 2 ·Cardiovascular

S52D DIGITAL VIDEO LAPAROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·VIS-SOL STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ISOTONIC STERILE UNPRESERVED SALINE SOLUTION

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD System (Version 3.3)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERIDYNE SOFT (HYDROPHILIC) LENS SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·VIS-SOL STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERILE PRESERVED SALINE SOLUTION

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ISOTONIC STERILE UNPRESERVED SALINE SOLUTION

SPIROTEQ

FDA 510(k)

FDA Class 2 ·Anesthesiology

Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems

FDA 510(k)

FDA Class 2 ·Radiology

Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems

FDA 510(k)

FDA Class 2 ·Radiology

AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10

FDA 510(k)

FDA Class 2 ·Radiology

AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems

FDA 510(k)

FDA Class 2 ·Radiology

Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems

FDA 510(k)

FDA Class 2 ·Radiology

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