ETEST FOR GEMIFLOXACIN

FDA 510(k)

FDA Class 2 ·Microbiology

KIMAX REMOTE VIEWING STATION

FDA 510(k)

FDA Class 2 ·Radiology

BACTIDROP ACRIDINE ORANGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPECIFIC IGE EIA-TURBO ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ESSEX ENDOSCOPE, MODEL SXD-1000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BACTIGEN(R) H. INFLUENZAE TYPE B

FDA 510(k)

FDA Class 2 ·Microbiology

GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES

FDA 510(k)

FDA Class 2 ·Ophthalmic

ARTHREX ARTHOERESIS IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

PEAK FLOW MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYRINGEFILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO EPTFE GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

DRUG DISPENSING SPIKE

FDA 510(k)

FDA Class 2 ·General Hospital

TEEN 100

FDA 510(k)

FDA Class 2 ·Anesthesiology

1570 - FETAL BLOOD SAMPLING KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology