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

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

PROSPECT SHIGA TOXIN MICROPLATE ASSAY

FDA 510(k)

FDA Class 1 ·Microbiology

MAURICE WORLDWIDE SHUNT SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

SYSMEX SE/RAM-1

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX CA-1000/SYSMEX CA-5000

FDA 510(k)

FDA Class 2 ·Hematology

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HC2 SYSTEM SOFTWARE

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·cobas HPV Test

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·cobas HPV Test, 240 Tests, cobas HPV Test, 960 Tests

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE 2 HPV DNA TEST

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PROSTATRON