CARPEDIEM System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMS100 Tri-Wave Combination Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

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

BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NQ TMS for MDD (NQv1-MU-01)

FDA 510(k)

FDA Class 2 ·Neurology

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