Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·SURGILENE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTHERM SOL.

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·TCO2M MODEL 818 MONITOR

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN HYDROCARE PRESERVED SALINE SOLUTION, SORBICARE SALINE, AND PRESERVED SALINE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTLENS CLEANING AND SOAKING SOL.

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR HCV TEST, V2.0

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·SHARP NEEDLE DESTRUCTION UNIT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·REMEDY CORONARY BALLOON DILATATION INFUSION CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SENSITIVE EYES(TM) SALINE SOLUTION

Suture, Absorbable, Synthetic, Polyglycolic Acid

FDA Pre-Market Approval

FDA Class 2 ·DEXON

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS FRESH(TM) LUBRICATING & REWETTING SOLN

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas CMV test for use on the cobas 6800/8800 System

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas® CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQ/MAN CYTOMEGALOVIRUS TEST

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER, MODEL HM3

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

FDA Pre-Market Approval

FDA Class 2 ·BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM