THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE

FDA 510(k)

FDA Class 2 ·Microbiology

Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EQUAL DOSE 1.0

FDA 510(k)

FDA Class 2 ·Radiology

TRIANGLE SLING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SARNS SOFT-FLOW AORTIC CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

TOMEY EM-1000 SPECULAR MICROSCOPE

FDA 510(k)

FDA Class 2 ·Ophthalmic

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit

FDA 510(k)

FDA Class 2 ·Microbiology

RADIFOCUS GUIDE WIRE M

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICROTEK TOTAL OSSICULAR PROTHESIS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SAPPHIRE ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CSI/MPR OR CSI/MPR PLUS

FDA 510(k)

FDA Class 2 ·Radiology

SUPRAMESH EXTRA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS

FDA 510(k)

FDA Class 2 ·Microbiology

ZQUIET MOUTHPIECE

FDA 510(k)

FDA Class 2 ·Dental

Glidesheath Slender Tibial Pedal Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SENSIBEAD EIA DIGOXIN KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CLIRANS E-SERIES HOLLOW FIBER DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology