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

SMART-READ EZTEST-STEAM SCBI AND TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO FLUROTEX SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

ESCHMANN ELECTROSURGICAL UNIT, MODEL TD411

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PHAKOSYSTEMS CT-100 CAUTERY MODULE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VISION CARE/PHAKOSYSTEMS ECHORULE

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System

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

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System

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

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA

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

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA

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

FDA Pre-Market Approval

FDA Class 2 ·AIA-PACK PA PSA, ST AIA-PACK PA PSA

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM/TOTAL PSA