ASAHI AM SERIES DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED SEPACELL R-SERIES BLOOD FILTERS

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT

FDA 510(k)

FDA Class 2 ·General Hospital

HEMOSORBA CH-500, CH-350 AND CH-180

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SEPACELL R-500 & SEPACELL R-500A

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLOOD PLATELET ASSAY METHOD & APPARATUS

FDA 510(k)

FDA Class 2 ·Hematology

MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS

FDA 510(k)

FDA Class 2 ·General Hospital

NEW AM-SERIES DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SEPACELL R-500 AND SEPACELL R-500A

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFIED AM-SERIES DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX STREAK & ACS FLOW TRACK 40

POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A

FDA 510(k)

FDA Class 2 ·Anesthesiology

Portable ECG Monitor (ECG3)

FDA 510(k)

FDA Class 2 ·Cardiovascular

BP5S Wireless Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Eye Tray

FDA classification

FDA Class 2 ·Eye Tray

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE

Monitor, Eye Movement

FDA classification

FDA Class 2 ·Monitor, Eye Movement

Implant, Eye Valve

FDA classification

FDA Class 2 ·Implant, Eye Valve