THD

FDA 510(k)

FDA Class 2 ·Radiology

GentleCath Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)

FDA 510(k)

FDA Class 2 ·Microbiology

MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF

FDA 510(k)

FDA Class 2 ·Neurology

FLEXLAB 3.6, ACCELERATOR A3600

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H

FDA 510(k)

FDA Class 2 ·Cardiovascular

Flexi-Seal PROTECT Fecal Management System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Glide Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Glide Intermittent Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43R HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·V-X (POLYMACON) ASPHERIC SOFT(HYDROPHILIC) LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

CURIETRON 192 LOW DOSE RATE

FDA 510(k)

FDA Class 2 ·Radiology

QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTASE PHE/GAL SCREENING ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PC-180 / PRINCE 180 EASY ECG MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular