Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR PICO RUNNER(TM) PTCA CATHETER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK DIGITAL

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anti-HCV Immunoassay

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA Centaur® HCV assay

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX(R) HAVAB(R)-M

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM ANTI-HCV

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·FLEX-CARE(R) RINSING, DISINFECTING, AND STORAGE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-SOAK(TM) CONDITIONING SOLUTION WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALCON SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-FREE(R) SUPRACLENS(TM) DAILY PROTEIN REMOVER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALCON MULTI-PURPOSE SOLUTION ID 81573

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Aptima CMV Quant Assay

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MEDSTONE STS(TM) LITHOTRIPTER

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SIEMENS MAMMOMAT NOVATION FULL FIELD DIGITAL MAMMOGRAPHY (FFDM)SYSTEM

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER MOBILE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·AFFINITY ANTERIOR CERVICAL CAGE SYSTEM