MERIDIAN ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

KOAGULAB* 32-S COAGULATION SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

AT-III CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO RESTORATION MODULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PREGNANCY CARD TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSCREEN FP FOR CANNABINOIDS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #)

FDA 510(k)

FDA Class 2 ·Orthopedic

VICRYL* POLYGLACTIN 730 ABSORBABLE STAPLES/STAPLER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST

FDA 510(k)

FDA Class 2 ·Microbiology

EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Fujifilm Diathermic Slitter (FlushKnife)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)

FDA 510(k)

FDA Class 2 ·Immunology

INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEW COMFORT CONTACT LENS CARE ACCESSORY

FDA 510(k)

FDA Class 2 ·Ophthalmic

Reflect Implant System

FDA 510(k)

FDA Class 2 ·Dental

THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEMOCHRON ONESTEP APTT TEST

FDA 510(k)

FDA Class 2 ·Hematology

AGFA DIAGNOSTIC CENTER (ADC)

FDA 510(k)

FDA Class 2 ·Radiology