Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KAINOX RV-S/ KAINOX VCS ICD LEADS

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR,INC. MODELS 1

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PRIME{TM} MODEL 6520, 6525, 6530 AND 6535

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·artus CMV RGQ MDx Kit and artus CMV QS_RGQ MDx Kit

Suture, Nonabsorbable, Synthetic, Polyamide

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, NYLON

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM (PAFLUFOCON A, B, AND C) CONTACT LENS

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

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

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

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

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRASOFT (METHAFILCON A) CONTACT LENS

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·DIASONICS NMR IMAGING SYSTEM

Suture, Absorbable, Synthetic, Polyglycolic Acid

FDA Pre-Market Approval

FDA Class 2 ·PDS(TM) SUTURE (CLEAR)

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·CATGUT SUTURE

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SODIUM CHLORIDE TABLETS, USP

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·PLAIN GUT SUTURES

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TRIPTER-X1 NOVA

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRON HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRASOFT (METHAFILCON B) CONTACT LENS