System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS(R) RX FLOWTRACK(TM) 40 CORONARY DILITATIN CATH

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOIL N SOAK CONTACT LENS FLUID

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) PTCA CATHETER

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL K

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC MAXXUM PTCA CATHETER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CIBATINT(TM) TINTING PROCESS

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·MAGNETOM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

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

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFT MATE WEEKLY CLEANING SOLUTION

Transducer, Ultrasonic, Obstetric

FDA Pre-Market Approval

FDA Class 2 ·TENNANT(TM) & KELMAN(TM) TYPE II

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·THE BLAIREX SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC BUSHBINDER(R) OMNIFLEX(TM) PTCA CATHETER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

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

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·TCO2M MODEL 818 MONITOR

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MIC TEST SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·MIC PANELS