EMC MODEL STATOME 200

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIO SM IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

IMMUNOGLOBULIN M TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ACE UNILATERAL FIXATOR II

FDA 510(k)

FDA Class 2 ·Orthopedic

MICRO THERM MT-500 & MT-600

FDA 510(k)

FDA Class 2 ·General Hospital

AED CYSTOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Occlusion Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL AU-1 ACCESSORY UNIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2

FDA 510(k)

FDA Class 2 ·Hematology

HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA

FDA 510(k)

FDA Class 2 ·General Hospital

HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMMULITE CMV IGG

FDA 510(k)

FDA Class 2 ·Microbiology

10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COAT-A-COUNT NEONATAL TSH IRMA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TENONE(TM) METHAMPHETAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

IMMULITE 2000, IMMULITE 2500 VANCOMYCIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GUIDE WIRE INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

TOA MEDICAL ELECTRONICS CA-5000

FDA 510(k)

FDA Class 2 ·Hematology

IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry