Bi-Flex Evo

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RADS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

FDA classification

FDA Class 2 ·Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Colon Computed Tomography System, Computer Aided Detection

FDA classification

FDA Class 2 ·Colon Computed Tomography System, Computer Aided Detection

AGFA CR50.0

FDA 510(k)

FDA Class 2 ·Radiology

PRESSON ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP

FDA 510(k)

FDA Class 2 ·Anesthesiology

L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC

FDA 510(k)

FDA Class 2 ·Radiology

UNILYTE A

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GLUCOMMANDER PLUS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Ti3Z Cervical Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PRESSUREGUARD IV

FDA 510(k)

FDA Class 2 ·General Hospital

FLEXICAIR EXLIPSE

FDA 510(k)

FDA Class 2 ·Physical Medicine

Z-LINK CERVICAL

FDA 510(k)

FDA Class 2 ·Orthopedic

MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

DURALASTIC I

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat