Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ALGES(TM) (HEFILCON A) CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SENSITIVE EYES(TM) SALINE SOLUTION

Filter, Intravascular, Cardiovascular

FDA Pre-Market Approval

FDA Class 2 ·COOK BIRD'S NEST VENA CAVA FILTER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SLINKY(TM) PTCA CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

Suture, Nonabsorbable, Synthetic, Polypropylene

FDA Pre-Market Approval

FDA Class 2 ·GORE-TEX(R) EXPANDED PTFE SUTURE

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 V2.0

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS TRASKAR 18 PTCA DILITATION CATHETERS

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

FDA Pre-Market Approval

FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEX 2 GRAM NEGATIVE AST FOR AMPICILLIN/SULBACTAM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER & USCI XPRT WITH PRO/PEL COATING BALLOON DILATATION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BRITE STOCK CLEANING / DISINFECTING SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CIBA VISION LENS DROPS