Coeur Laboratories, Inc.

FDA Regulatory Profile

Coeur Laboratories, Inc. appears in FDA public data with 0 recalls, 10 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on October 8, 1997.

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K971712COEUR 130 ML ANGIOGRAPHIC SYRINGEOctober 8, 1997
K965214COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)March 28, 1997
K960965FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211September 12, 1996
K890292PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGEJune 22, 1989
K885138CAPILLARY TUBE, BLOOD COLLECTIONFebruary 7, 1989
K88520216 LONG CATHETER W/ADAPTER, 14 FR AND 12 FRJanuary 31, 1989
K881646UROLOGICAL CATHETERJune 16, 1988
K874579COEUR CONTROL SYRINGEJanuary 19, 1988
K873597TUBING, POLYETHYLENENovember 12, 1987
K823920COEURLOCK STERILE DISPOS. ANGIOGRAPHICFebruary 18, 1983