Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000 SYSTEM

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

Suture, Absorbable, Synthetic

FDA Pre-Market Approval

FDA Class 2 ·VICRYL MESH

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Suture, Surgical, Absorbable, Polydioxanone

FDA Pre-Market Approval

FDA Class 2 ·PDS SUTURE (DYED)

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·DIASONICS NMR IMAGING SYSTEM

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS

Suture, Absorbable

FDA Pre-Market Approval

FDA Class 2 ·COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRASOFT (METHAFILCON A) CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S

Radioimmunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·CYCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS

Suture, Nonabsorbable, Synthetic, Polyamide

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, NYLON

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·ENDURANCE BONE CEMENT

Suture, Surgical, Absorbable, Polydioxanone

FDA Pre-Market Approval

FDA Class 2 ·PDS SUTURE (DYED)

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

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