Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK (SL) CAD

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS

Suture, Nonabsorbable, Silk

FDA Pre-Market Approval

FDA Class 2 ·SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ICAD SYSTEM

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·VASCUTEK GELSEAL(TM) VASCULAR GRAFT

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·PRO-TRAC II TACROLIMUS ELISA KIT

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRON HYDROPHILIC CONTACT LENS

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

FDA Pre-Market Approval

FDA Class 2 ·AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRON SEMI SCLERAL, MINI, TORIC

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·BELOS VR ICD SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000 SYSTEM

Filter, Intravascular, Cardiovascular

FDA Pre-Market Approval

FDA Class 2 ·GIANTURCO-ROEHM BIRD'S NEST(TM) VENA CAVA FILTER

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Artus CMV RGQ and QS-RGQ MDx Kit

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·CATGUT SUTURE

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·METROSOFT(DELTAFILCONA) HYDROPHILIC CONTACT LENSES

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·ETHIBOND*

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·PLAIN GUT SUTURES