System/Device, Pharmacy Compounding

FDA classification

FDA Class 2 ·System/Device, Pharmacy Compounding

AURIS AEP

FDA 510(k)

FDA Class 2 ·Neurology

COBE AEPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

A-LINE AEP MONITOR

FDA 510(k)

FDA Class 2 ·Neurology

CYTOVISION FOR CEP XY

FDA 510(k)

FDA Class 2 ·Immunology

RUBBER CONTRACEPTIVE (CONDOM)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK

FDA 510(k)

FDA Class 2 ·Ophthalmic

STERILS SINGLE-USE I/A HANDPIECES

FDA 510(k)

FDA Class 2 ·Ophthalmic

SAMUELS - MICRO -SCLER CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

E.N.S.I. RETRACTABLE SAFETY SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

STELLARIS PC VISION ENHANCEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

CELL COLLECTING BRUSH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Brainance MD

FDA 510(k)

FDA Class 2 ·Radiology

Advantis Platform

FDA 510(k)

FDA Class 2 ·Radiology

CEP 8 SPECTRUMORANGE DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

VYSIS D7S486/CEP 7 FISH PROBE KIT

FDA 510(k)

FDA Class 2 ·Hematology

CARTO 3 EP Navigation System Version 7.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2

FDA 510(k)

FDA Class 2 ·Cardiovascular