Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·ETHIBOND*

Suture, Surgical, Absorbable, Polydioxanone

FDA Pre-Market Approval

FDA Class 2 ·PDS SUTURE (DYED)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

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

Ultrasound, Cyclodestructive

FDA Pre-Market Approval

FDA Class 2 ·THERAPEUTIC ULTRASOUND FOR TREATMENT OF GLAUCOMA

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·CHROMIC GUT SUTURE

Suture, Nonabsorbable, Silk

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, BRAIDED SILK

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM (PAFLUFOCON A,B,C )VIOLET TINT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW(TM) RADIOPAQUE BONE CEMENT, HALF PACK

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR PICOCATH(TM) MODEL PICO-ST

Radioimmunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·1YCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS

Suture, Absorbable, Synthetic, Polyglycolic Acid

FDA Pre-Market Approval

FDA Class 2 ·PDS(TM) SUTURE (CLEAR)

Suture, Nonabsorbable, Silk

FDA Pre-Market Approval

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

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·COLLAGEN SUTURE (PLAIN CHROMIC) ABSORBABLE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK (SL) CAD

Suture, Nonabsorbable, Silk

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, BRAIDED SILK

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KENTROX RV-S/KENTROX SL-S ICD LEADS

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·ENDURANCE BONE CEMENT

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)