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

SPY Portable Handheld Imaging (SPY-PHI) System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101

FDA 510(k)

FDA Class 2 ·General Hospital

EPOC BLOOD ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CRYOcheck FVIII Inhibitor Kit

FDA 510(k)

FDA Class 2 ·Hematology

SPECTROLYSE/PL PAI KIT

FDA 510(k)

FDA Class 2 ·Hematology

Collagentex Rx-6

FDA 510(k)

FDA Class 2 ·Physical Medicine

Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray

FDA 510(k)

FDA Class 2 ·Neurology

MEA110

FDA 510(k)

FDA Class 2 ·Neurology

3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory

FDA 510(k)

FDA Class 2 ·Radiology

Modus Nav

FDA 510(k)

FDA Class 2 ·Neurology

THE WESTERN CORTICAL ELECTRODE ARRAY

FDA 510(k)

FDA Class 2 ·Neurology

TECHFIL

FDA 510(k)

FDA Class 2 ·Anesthesiology