Medical Device Manufacturer · US , New York , NY

Toray Industries (America), Inc. - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 1986

18

Total

18

Cleared

0

Denied

FDA 510(k) Regulatory Record - Toray Industries (America), Inc. Gastroenterology & Urology ✕

9 devices

1-9 of 9

Cleared Sep 29, 2003

TORAYSULFONE DIALYZER, BS-L SERIES

Gastroenterology & Urology · 266d

Cleared Oct 15, 2001

TORAYSULFONE DIALYZER

Gastroenterology & Urology · 426d

Cleared Aug 25, 2000

HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L

Gastroenterology & Urology · 256d

Cleared Jun 22, 1995

Gastroenterology & Urology · 380d

Cleared May 19, 1995

Gastroenterology & Urology · 550d

Cleared May 04, 1995

Gastroenterology & Urology · 433d

Cleared Mar 17, 1989

TORAY FILTRYZER DIALYZERS

Gastroenterology & Urology · 154d

Cleared Feb 27, 1989

TORAY FILTRYZER BK SERIES

Gastroenterology & Urology · 200d

Cleared Aug 12, 1988

MODIFIED TORAY FILTRYZER DIALYZERS

Gastroenterology & Urology · 81d