SURVIVAL KIT

FDA 510(k)

FDA Class 1 ·General Hospital

DURA-PATCH MODEL DP-XXX

FDA 510(k)

FDA Class 2 ·Neurology

EZTEST-STEAM

FDA 510(k)

FDA Class 2 ·General Hospital

PROLITE III TOWER AND PR AND HR HANDPIECE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

X-spine Cortical Bone Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Cortera™ Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

ALLOX2 TISSUE EXPANDERS

FDA 510(k)

FDA Unclassified ·Unknown

SMART-READ EZTEST-STEAM SCBI AND TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

ACCOMMODATOR WHEELCHAIR, MODEL #2000X

FDA 510(k)

FDA Class 1 ·Physical Medicine

MODIFICATION TO FLUROTEX SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAMMARY SIZER

FDA 510(k)

FDA Unclassified ·Unknown

VIRILIS PENILE PROSTHESIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SILICONE ELASTOMER SHEETING

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PROLITE PULSED LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO FLUOROTEX II SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TERRA FEMME

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISIAN ICL)

Paste, Injectable For Vocal Cord Augmentation

FDA Pre-Market Approval

FDA Class 3 ·MENTOR POLYTEF PASTE /FOR INJECTION

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·Artisan Myopia