ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)

FDA 510(k)

FDA Class 2 ·Hematology

ASA ORAL APPLIANCES

FDA 510(k)

FDA Class 2 ·Dental

SnugFit ASA Extension

FDA 510(k)

FDA Class 2 ·Orthopedic

ASA LASER SH1

FDA 510(k)

FDA Class 2 ·Physical Medicine

LASERMATIC SURGILASER MODEL 5050

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST MOXIFLOXACIN 0.002-32 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST Telavancin (TLA) (0.002-32 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

CHROMID CARBA agar (CARB)

FDA 510(k)

FDA Class 2 ·Microbiology

RAPIDEC CARBA NP

FDA 510(k)

FDA Class 2 ·Microbiology

CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOPULMONARY BYPASS PUMP TUBING

FDA 510(k)

FDA Class 2 ·Cardiovascular

VACUUM-ASSISTED BLOOD COLLECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wireless/ Wired X-Ray Flat Panel Detectors

FDA 510(k)

FDA Class 2 ·Radiology

SOMATOM Definition AS/AS+

FDA 510(k)

FDA Class 2 ·Radiology

BOVINE SERUM ALBUMIN (BSA)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ASA BLOOD TUBING LINES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MANUEL SAFTEY SYRINGE PARTS 1 & 2

FDA 510(k)

FDA Class 2 ·General Hospital

LEADCARE BLOOD LEAD TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology