Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MEDSTONE STS(TM) LITHOTRIPTER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER (CAD) SYSTEM, M100

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·STORZ MODULITH LITHOTRIPTER, MODEL SLX

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·DIAGNOSTIC/ABLATION DEFLECTABLE BRAIDED-TIP CATHETER (WITHOUT THERMOCOUPLE) & CELSIUS (WITH THERMOCOUPLE)

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVI-STAR and EZ Steer Nav Bi-Directional Catheter

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·EZ Steer Navigational 4mm (TC)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Atellica IM Hepatitis C (aHCV)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ACHITECT ANTI-HCV

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

System, Water Purification, General Medical Use

FDA classification

FDA Class 2 ·System, Water Purification, General Medical Use

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY

Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue

FDA classification

FDA Class 2 ·Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue

Strabismus Detection Device

FDA classification

FDA Class 2 ·Strabismus Detection Device

Catheter, Intravascular, Plaque Morphology Evaluation

FDA classification

FDA Class 2 ·Catheter, Intravascular, Plaque Morphology Evaluation

Ultrasound, Infusion, System

FDA classification

FDA Class 2 ·Ultrasound, Infusion, System