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

CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS

FDA 510(k)

FDA Class 2 ·Cardiovascular

COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EVERON

FDA 510(k)

FDA Class 2 ·Anesthesiology

FUJIFILM Endoscope Model EG-530N

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

AISAP Cardio V1.0

FDA 510(k)

FDA Class 2 ·Radiology

TEEN 100

FDA 510(k)

FDA Class 2 ·Anesthesiology

1570 - FETAL BLOOD SAMPLING KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology