Toray Industries (America), Inc.

FDA Regulatory Profile

Toray Industries (America), Inc. appears in FDA public data with 0 recalls, 18 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on December 17, 2004.

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K042370TORAYGUIDE GUIDEWIREDecember 17, 2004
K030050TORAYSULFONE DIALYZER, BS-L SERIESSeptember 29, 2003
K002512TORAYSULFONE DIALYZEROctober 15, 2001
K994198HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0LAugust 25, 2000
K942681FILTRYZERJune 22, 1995
K935471FILTRYZER(TM)May 19, 1995
K940910FILTRYZERMay 4, 1995
K884339TORAY FILTRYZER DIALYZERSMarch 17, 1989
K883407TORAY FILTRYZER BK SERIESFebruary 27, 1989
K884083TORAY VASCULAR PROSTHESISJanuary 12, 1989
K882158MODIFIED TORAY FILTRYZER DIALYZERSAugust 12, 1988
K881236TORAY ANTHRON P-U CATHETERSMay 11, 1988
K874542TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPESMarch 7, 1988
K872983TORAY ANTHRON ANGIOGRAPHIC CATHETERSNovember 20, 1987
K872762TORAY ANTHRON AORTA BYPASS TUBESSeptember 24, 1987
K861115TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPEJuly 11, 1986
K861117ANTHRON CATHETERS & SETSJune 18, 1986
K861116TORAY ANTHRON BYPASS TUBESMay 28, 1986