XTRAC EXCIMER LASER SYSTEM, MODEL AL7000

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DRI PRIMIDONE CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Acuson SC2000 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENDERO Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aptima BV Assay; Aptima CV/TV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755

FDA 510(k)

FDA Class 2 ·Cardiovascular

LAURIMED SPINAL INJECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

LABELING CHANGE AMPHETAMINE DOUBLE ANTIBODY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MYSAFETY SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

Medtronic DUET External Drainage and Monitoring System

FDA 510(k)

FDA Class 2 ·Neurology

GAS-VAK(R), MODEL 300

FDA 510(k)

FDA Class 2 ·Anesthesiology

M-70 GOLD BASE DENTAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

ARGENCO 10 TYPE I DENTAL GOLD ALLOY

FDA 510(k)

FDA Class 2 ·Dental

BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ISOFLO(TM) HIGH PRESSURE INJECTION LINES

FDA 510(k)

FDA Class 2 ·Cardiovascular

BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS)

FDA 510(k)

FDA Class 2 ·Immunology

VISION BG TEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry