SIMMONS PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)

FDA 510(k)

FDA Class 2 ·Orthopedic

RESUBMITTING OF HJD TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VENTILATION TUBES WITH HYDROGEL COATING

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

RICHARD ARTHROSCOPE

FDA 510(k)

FDA Class 2 ·Orthopedic

TI-FIT ACETABULAR COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

MODULAR COLLARED HJD TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

COFIELD SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS

FDA 510(k)

FDA Class 2 ·Radiology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM/TOTAL PSA

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCHNEIDER PTCA CATHETERS

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY TFC UNITE PRODUCT LINE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY THREADED FUSION CAGE(TFC)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BOSTON SCIENTIFIC MAVERICK 2 PTCA CATHETER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPID SCREEN RS-2000, RS-2000D AND RS-DIGITAL

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PRECISION ULTRAVIOLET (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR