COMPLETE BRAND LUBRICATING AND REWETTING DROPS

FDA 510(k)

FDA Class 2 ·Ophthalmic

DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALERT

FDA 510(k)

FDA Class 2 ·Dental

CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)

FDA 510(k)

FDA Class 2 ·Hematology

PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IL MCL-2 COAGULATION ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL #M9 ULTRACLAVE STEAM STERILIZER

FDA 510(k)

FDA Class 2 ·General Hospital

ARCPM 1050 RESIN-HIPS

FDA 510(k)

FDA Class 2 ·Orthopedic

SRI 100 RADIOTHERAPY IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

USS-LINE EXTENSION

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER

FDA 510(k)

FDA Class 2 ·General Hospital

ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

USCI MACH 10 GUIDE WIRE WITH PRO/PEL COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

MCLEAN-STOCK PERCUTANEOUS T-TUBE SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

H-H VENTRICULAR CATHETERS & RESERVOIRS

FDA 510(k)

FDA Class 2 ·Neurology

PHILIPS DIAGNOST 96

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO COOK ZILVER BILIARY STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELECSYS PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology