REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SILIMED PECTORAL IMPLANT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

QA-ES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROSTIM 1000/2000

FDA 510(k)

FDA Class 2 ·Neurology

PRODIGY DIABETES MANAGEMENT SOFTWARE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NANMA NON-ADJUSTABLE CONSTRICTION RING

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOSLEEVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

EBONY PTA .035 PERIPHERAL DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DAUM NEUROCUT NEUROBIOPSYNEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WAVESTATE NEUROMONITOR

FDA 510(k)

FDA Class 2 ·Neurology

ILO292 DP ECHOPORT PLUS OAE SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BREATHERITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

DAUM ASPIRATIONBIOPSY NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STAR (LUNAR SERIES) MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

THE WATER LILY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TOPOGRAPHIC IMAGING MARKER

FDA 510(k)

FDA Class 2 ·Radiology

NEEDLE INCAPACITATOR (NEEDLE GUARD)

FDA 510(k)

FDA Class 2 ·General Hospital