HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2

FDA 510(k)

FDA Class 2 ·Cardiovascular

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

QR-50-E DISPOSABLE RADIOTRANSLUCENT ECG ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22

FDA 510(k)

FDA Class 2 ·Radiology

MEDICOTEST ECG ELECTRODES

FDA 510(k)

FDA Class 2 ·Cardiovascular

ABUSCREEN FP FOR BARBITURATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CHURCHILL INJECTION SITE

FDA 510(k)

FDA Class 2 ·General Hospital

STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4

FDA 510(k)

FDA Class 2 ·Radiology

STORM TDX POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

CORVUS RADIATION THERAPY PLANNING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ABUSCREEN ONTRAK FOR BENZODIAZEPINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC

FDA 510(k)

FDA Class 2 ·Radiology

LTM-BPS SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SJM TAILOR ANNULOPLASTY RING, MODEL TARN

FDA 510(k)

FDA Class 2 ·Cardiovascular

HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Indigo Aspiration System

FDA 510(k)

FDA Class 2 ·Cardiovascular