QLT ABSOLUTE URINE-HCG PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Cerebra Sleep System

FDA 510(k)

FDA Class 2 ·Neurology

Integrity V500 (Integrity, Integrity with VEMP)

FDA 510(k)

FDA Class 2 ·Neurology

NON-STERILE SURGICAL MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACU-RAY HF SERIES PORTABLE X-RAY UNIT

FDA 510(k)

FDA Class 2 ·Radiology

SUREFLEX STEERABLE GUIDING SHEATH KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIVOSONIC NEUROSCREEN

FDA 510(k)

FDA Class 2 ·Neurology

AMP ALKALINE PHOSPHATASE REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SONIX ULTRASOUND SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

Tulsa-Pro System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CADI, VERSION 4

FDA 510(k)

FDA Class 2 ·Radiology

AUTOVENT 1000

FDA 510(k)

FDA Class 2 ·Anesthesiology

XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

SPECTROLYSE PLASMINOGEN SK KIT

FDA 510(k)

FDA Class 2 ·Hematology

THE SILENCER

FDA 510(k)

FDA Class 2 ·Dental

BREATH-TAKER BREATH-ALERT

FDA 510(k)

FDA Class 2 ·Anesthesiology

XLTEK LED GOGGLES, MODEL LED-01

FDA 510(k)

FDA Class 2 ·Neurology

OsteoCool V-2 RF Ablation System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ROSA® Knee System

FDA 510(k)

FDA Class 2 ·Neurology

PRIMED Surgical Masks and PRIMED Procedure Masks

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery