Medical Device Manufacturer · US , Carolina Puerto Rico

Customed, Inc. - FDA 510(k) Cleared Devices

36 submissions · 26 cleared · Since 1990

Recent clearances: FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633, GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522), SUCTION CATHETER TRAY PRODUCT NO. 900277

36

Total

26

Cleared

0

Denied

FDA 510(k) Regulatory Record - Customed, Inc. Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Oct 04, 1996

URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)

Gastroenterology & Urology · 88d

Cleared May 09, 1996

UNIVERSAL DRAINAGE TRAY

Gastroenterology & Urology · 24d

Cleared Sep 08, 1994

FOLEY CATHETERIZATION TRAY

Gastroenterology & Urology · 127d

Cleared Sep 20, 1990

CUSTOMED CYSTO PACK I

Gastroenterology & Urology · 122d