STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

KOLPLAST VAGINAL SPECULUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITEK 2 AST ST MEROPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

WHISTLE WATCH

FDA 510(k)

FDA Class 2 ·Anesthesiology

PLATO BRACHYTHERAPHY, MODEL V. 14.0

FDA 510(k)

FDA Class 2 ·Radiology

MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LASERTOUCHONE (OTC)

FDA 510(k)

FDA Class 2 ·Neurology

SILIMED GLUTEAL IMPLANT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY

FDA 510(k)

FDA Class 2 ·Dental

Eversense AP CGM System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER

FDA 510(k)

FDA Class 2 ·General Hospital

PR-3 ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

VITEK 2 GRAM POSITIVE MEROPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

GLUCOSE(TRINDER) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM

FDA 510(k)

FDA Class 2 ·Microbiology