Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA Centaur® HCV assay

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY(TM) VAGINAL POUCH

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·cobas HCV

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

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA, free PSA Calset, free PSA CalCheck

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·MENICON SF-P RGP (MELAFOCON A) CONTACT LENS

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·SONOLITH 3000 LITHOTRIPTER

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KENTROX RV LEAD SYSTEMS

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALCON ENZYME CLEANER

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·BOSTON EQUALENS(R) AND BOSTON RXD(R)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TORIC AND OPTIMA (HEFILCON B) CONTACT LENSES

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·SHARPX NEEDLE DESTRUCTION UNIT

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TORIC AND OPTIMA (HEFILCON B) CONTACT LENSES

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY THREADED FUSION CAGE (TFC)

Glucose Oxidase, Glucose

FDA Pre-Market Approval

FDA Class 2 ·GLUCOWATCH (R) AUTOMATIC GLUCOSE BIOGRAPHER

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MICROSCAN RAPID FLUOROGENIC PANELS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CONTACLAIR MULTI-PURPOSE SOLUTION

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

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

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOSTON LENS(R) CLEANER