Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·KONTRON CUTANEOUS PCO2 MONITOR

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·HOLOGIC SAHARA CLINICAL BONE SONOMETER

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·GYREX, MODELS S3500 & S5000

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

FDA Pre-Market Approval

FDA Class 2 ·TOTAL PSA MICROTITER ELISA

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR GENTAMICIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·EDAP LT.02 SHOCK WAVE LITHOTRIPTER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·MENICON SUPER EX CONTACT LENS

Suture, Nonabsorbable, Synthetic, Polyamide

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, NYLON

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·THE HORIZON SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER (CAD) SYSTEM, M1000

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 SYSTEM

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·EDAP LT.01 SHOCK WAVE LITHOTRIPTER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PROMINENT CALC FEATURE MARKER

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR LEVOFLOXACIN