ACCESS HTSH ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OXYMAX

FDA 510(k)

FDA Class 2 ·Anesthesiology

Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level

FDA 510(k)

FDA Class 2 ·Neurology

QM300 CALIBRATOR D PACK

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OTC DDR

FDA 510(k)

FDA Class 2 ·Radiology

icobrain

FDA 510(k)

FDA Class 2 ·Radiology

Naviswiss Hip Navigation System

FDA 510(k)

FDA Class 2 ·Neurology

VIVOSORB SHEET, MODEL FS01

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ERKA. PERFECT-ANEROID

FDA 510(k)

FDA Class 2 ·Cardiovascular

QM300 CONTROL F PACK

FDA 510(k)

FDA Class 2 ·Immunology

TELEDYNE GETZ BARRIER-DENTIN SEALER

FDA 510(k)

FDA Class 2 ·Dental

KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography

FDA 510(k)

FDA Class 2 ·Radiology

ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479

FDA 510(k)

FDA Class 2 ·Microbiology

BoneTrust Mini Implant System

FDA 510(k)

FDA Class 2 ·Dental

ACCESS CK-MB REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PINPOINT Endoscopic Fluorescence Imaging System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VISUAL SERUM/URINE HCG COMBO KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS(R) CORTISOL REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS(R) FREE T4 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry