STERIZONE VP4 Test Pack

FDA 510(k)

FDA Class 2 ·General Hospital

MAGLUMI 2000 HCG/ß-HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Male Latex Condoms

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK TEST SERVICE

SURGICAL LIGHTING-CENTRA 450

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DELSONIC 2000

FDA 510(k)

FDA Class 2 ·Dental

JETSONIC 2000

FDA 510(k)

FDA Class 2 ·Dental

SPY Portable Handheld Imaging (SPY-PHI) System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Autoclave Indicator Tape; EO Indicator Tape

FDA 510(k)

FDA Class 2 ·General Hospital

SPY Elite Intraoperative Perfusion Assessment System

FDA 510(k)

FDA Class 2 ·Radiology