ClearanceBrief
Panels › Gastroenterology, Urology › Product code FCM · Class 2

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Regulation 876.5130

1510(k)s in 12 months (60 all time)
0recalls in 12 months (43 all time)
16recalls that name a 510(k)
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Top companies in FCM

Company510(k)sRecalls
Nurse Assist, Inc024
Latex Ind., Inc.80
Go Medical Industries Pty. , Ltd.25
Cardinal Health06
Concord Laboratories, Inc.50
Orion Life Systems, Inc.50
Customed, Inc.22
Amsino International, Inc.30
Snyder Laboratories, Inc.30
C.R. Bard, Inc.20
Decided510(k)Device and applicantCode
Feb 21, 1978K780123CATHETERIZATION PROCEDURE TRAY
Walpak Co.
FCM
Sep 20, 1977K771652CATH-CARE TRAY
Latex Ind., Inc.
FCM
Sep 20, 1977K771651AKRO-SIL FOLEY KIT 5CC
Latex Ind., Inc.
FCM
Sep 20, 1977K771650AKRO-SIL FOLEY KIT 30CC
Latex Ind., Inc.
FCM
Jun 24, 1977K771104URETHRAL TRAY W/OUT CAHTETER, 7650
Concord Laboratories, Inc.
FCM
Jun 24, 1977K771103URETHRAL TRAY W/CATHETER, 7750
Concord Laboratories, Inc.
FCM
Mar 21, 1977K770496UNIVERSAL TRAY
Concord Laboratories, Inc.
FCM
Mar 1, 1977K760048TRAY, URETHRAL CATHETERIZATION
M-C Ind., Inc.
FCM
Oct 7, 1976K760128TRAY, CATHETERIZATION W/ CATHETER
Concord Laboratories, Inc.
FCM
Oct 7, 1976K760127TRAY, CATHETERIZATION W/O CATHETER
Concord Laboratories, Inc.
FCM

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