Medical Device Manufacturer · US , Carolina Puerto Rico

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

36 submissions · 26 cleared · Since 1990

36

Total

26

Cleared

0

Denied

FDA 510(k) Regulatory Record - Customed, Inc. General Hospital ✕

14 devices

1-12 of 14

Cleared Jan 05, 1998

FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633

General Hospital · 24d

Cleared Dec 04, 1997

GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)

General Hospital · 195d

Cleared Oct 02, 1995

STERIMED STERIZATION WRAPPER (NON-STERILE)

General Hospital · 56d

Cleared Jun 07, 1993

IRRIGATION TRAY W/ BULB SYRINGE

General Hospital · 256d

Cleared Jan 02, 1991

CUSTOMED CARDIOVASCULAR PACK

General Hospital · 78d

Cleared Jan 02, 1991

CUSTOMED ANGIODRAPE PACK FEMORAL

General Hospital · 78d

Cleared Oct 31, 1990

CUSTOMED CYSTO PACK II

General Hospital · 202d

Cleared Oct 31, 1990

CUSTOMED LAP PACK II

General Hospital · 168d

Cleared Sep 19, 1990

CUSTOMED BASIC PACK I

General Hospital · 79d

Cleared Sep 19, 1990

CUSTOMED BASIC PACK II

General Hospital · 79d

Cleared Sep 19, 1990

CUSTOMED BASIC PACK III

General Hospital · 79d

Cleared Jul 12, 1990

CUSTOMED LAP PACK I

General Hospital · 69d