ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

520 DISPLAY DRIVER- STATUS I

FDA 510(k)

FDA Class 2 ·Cardiovascular

DYNASCOPE SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

ISOCAM II (DUAL HEAD GAMMA CAMERA)

FDA 510(k)

FDA Class 2 ·Radiology

TriVerity

FDA 510(k)

FDA Class 2 ·Microbiology

SeptiCyte RAPID

FDA 510(k)

FDA Class 2 ·Microbiology

SeptiCyte LAB

FDA 510(k)

FDA Class 2 ·Microbiology

SeptiCyte RAPID

FDA 510(k)

FDA Class 2 ·Microbiology

Rongeur, Cystoscopic, Hot

FDA classification

FDA Class 2 ·Rongeur, Cystoscopic, Hot

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Device, Pasteurization, Hot Water

FDA classification

FDA Class 2 ·Device, Pasteurization, Hot Water

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

FDA classification

FDA Class 2 ·Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Pack, Hot Or Cold, Water Circulating

FDA classification

FDA Class 2 ·Pack, Hot Or Cold, Water Circulating

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·\EART TRAK,HART TRAK III,MAX TRAK,MAX TRAK DP,PROA

Human Lyophilized Dura Mater

FDA classification

FDA Class 2 ·Human Lyophilized Dura Mater