RANDOX BARBITURATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEOSS VARIOUS TITANIUM ABUTMENTS

FDA 510(k)

FDA Class 2 ·Dental

Callaly Tampliner (super plus absorbency)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MOORLDLS-BI LASER DOPPLER BURNS IMAGER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PICO 7Y Single Use Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FLUME catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RANDOX LIQUID PROTEIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ORTHOVIEW

FDA 510(k)

FDA Class 2 ·Radiology

POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Shani Darden LED light therapy mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CLINIJEL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DIASTAT ANTI-THYROGLOBULIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITROS Immuodiagnostic Products CA 125 II Reagent Pack

FDA 510(k)

FDA Class 2 ·Immunology

handLITE (TN19S)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS

FDA 510(k)

FDA Class 2 ·Immunology