MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

DIGENE DCR-1 LUMINOMETER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

TOPOGRAPHIC IMAGING MARKER

FDA 510(k)

FDA Class 2 ·Radiology

RADIFOCUS(R) (CATHETER) GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

XERON PACS

FDA 510(k)

FDA Class 2 ·Radiology

AMCAD-UT DETECTION MODEL 2.0

FDA 510(k)

FDA Class 2 ·Radiology

VISIONTOOL

FDA 510(k)

FDA Class 2 ·Radiology

FUTREX-5000A

FDA 510(k)

FDA Class 2 ·Cardiovascular

WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CYTOGUARD(R)

FDA 510(k)

FDA Class 2 ·General Hospital

ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

AccuPoint Electrode

FDA 510(k)

FDA Class 2 ·Neurology

SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12

FDA 510(k)

FDA Class 2 ·Anesthesiology

SYNERGY

FDA 510(k)

FDA Class 2 ·Dental

EMBEDDING RINGS

FDA 510(k)

FDA Class 1 ·Pathology

PLANET 50 MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ActiPatch

FDA 510(k)

FDA Class 2 ·Physical Medicine

MANUAL STETOSCOPE

FDA 510(k)

FDA Class 1 ·Cardiovascular

BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology