NORDICICE SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO NORDICICE SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

AFINION ACR AND ACR CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Cary

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NORDICBRAINEX SOFTWARE, VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

nordicMEDiVA

FDA 510(k)

FDA Class 2 ·Radiology

ODI-Tech

FDA 510(k)

FDA Class 2 ·Cardiovascular

nordicBrainEx

FDA 510(k)

FDA Class 2 ·Radiology

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HEPATITIS C CHECK TESTING SERVICE

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C TEST SERVICE

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK TEST SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HEPATITS C CHECK TEST SYSTEM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK TEST