Acapella Cervical Spacer System

FDA 510(k)

FDA Class 2 ·Orthopedic

SeaSpine WaveForm, C Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

Stable-C Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

Pro-Link® Stand-Alone Cervical Spacer System

FDA 510(k)

FDA Class 2 ·Orthopedic

CAVUX CervicalCage-L SA System

FDA 510(k)

FDA Class 2 ·Orthopedic

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·O.P.R. -55 SOFT CONTACT LENS

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE-EASE TM 2501

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE-EASE MODEL 3500

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·O.P.R. -55 SOFT CONTACT LENS

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER

BIOJECTOR SYRINGE SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

PERSONAL INFUSOR

FDA 510(k)

FDA Class 2 ·General Hospital

FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

FLEXITRON

FDA 510(k)

FDA Class 2 ·Radiology

HIGH SPEED EMG MODULE

FDA 510(k)

FDA Class 2 ·Neurology

OHMEGA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MMS VIDEO OPTION

FDA 510(k)

FDA Class 2 ·Radiology

SOLAR GI SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO SOLAR GI

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology