TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CENTRAL VENOUS CATHETER W/BIG-GARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALLERG-E IGE ENZYME IMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

V-TREND DIG ENZYME IMMUNOASSAY TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Philips CT Big Bore Sliding Gantry Configuration

FDA 510(k)

FDA Class 2 ·Radiology

SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

OR SPECIFIC BIG CASE BACK TABLE COVER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DynaMesh-POSTERIOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DynaMesh-VENTRAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DYNAMESH -CICAT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROLITE PULSED LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC BIG RANGER PTCA CATHETER

LOW FLUID ALARM

FDA 510(k)

FDA Class 2 ·General Hospital

AMBULATORY ECG DIGITAL MONITOR MODEL: TD-30

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEBP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OMRON AUTO OSCILLOMETRIC DIG BP MONT/HEM-704C 705C

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2

FDA 510(k)

FDA Class 2 ·Clinical Toxicology