Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·SURGILENE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS-WET(TM)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTHERM SOL.

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·AQUA SOFT CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·DURACLEAN(TM) DAILY CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTMATE SOL.

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED NC BIB RANGER PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·APEX MONORAIL & OVER-THE-WIRE PTCA CATHETERS

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST

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

FDA Pre-Market Approval

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

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·DE-STAT 3 CLEANING SOAKING CONDITIONING SOLUTION

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED MAVERICK(TM) MONORAIL(TM) (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS, OMEGA DILITATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CHANGES TO ALPHA /STREAK ADD BALLOON LENGTHS

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV TEST VERSION 2.0

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTHERM SOL.