Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·O.P.R. -55 SOFT CONTACT LENS

INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

EVERON

FDA 510(k)

FDA Class 2 ·Anesthesiology

AUTOSET SPIRIT SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

ENDOFORM RECONSTRUCTIVE TEMPLATE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PVC FREE INTRAVASCULAR ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS

FDA 510(k)

FDA Class 2 ·General Hospital

ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Habib EUS RFA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENABLER-P CATHETER SYSTEM, MODEL 3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

NIO-I

FDA 510(k)

FDA Class 2 ·General Hospital

ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HealthBeacon HB2 Sharps Bin

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO E.P.T. PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO EPTFE GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

AEROSOL INHALATION MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

EPT CERTAINTY PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ENDOFLIP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology