TRITON MEIDCAL TMED IV-SET

FDA 510(k)

FDA Class 2 ·General Hospital

Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

REVISED LABELING FOR LSD TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSCREEN (R) EIA BARBITURATE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Neon EEG

FDA 510(k)

FDA Class 2 ·Neurology

Vascu-Guard Vascular Repair Patch

FDA 510(k)

FDA Class 2 ·Cardiovascular

iExaminer System with Panoptic Plus

FDA 510(k)

FDA Class 2 ·Ophthalmic

XVIEWNET

FDA 510(k)

FDA Class 2 ·Radiology

ECG Disposable Lead Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular

X-Tack Endoscopic HeliX Tacking System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMIPENEM SUSCEPTIBILITY POWDER

FDA 510(k)

FDA Class 2 ·Microbiology

REVISED LABELING FOR MORPHINE TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR ABUSCREEN EIA BARBITURATE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ONTEX TAMPON (UNSCENTED)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BF-NAVI

FDA 510(k)

FDA Class 2 ·Radiology

BELLECUP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CERAROOT IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental