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 & Plastic Surgery ✕

10 devices

1-10 of 10

Cleared Nov 25, 1996

SUCTION CATHETER TRAY PRODUCT NO. 900277

General & Plastic Surgery · 49d

Cleared Apr 18, 1995

WOUND CLOSURE/LACERATION TRAY

General & Plastic Surgery · 84d

Cleared Aug 27, 1993

IV PREP KIT (NON-STERILE)

General & Plastic Surgery · 337d

Cleared Aug 27, 1993

IV PREP KIT W/O DRESSING (NON-STERILE)

General & Plastic Surgery · 337d

Cleared Jun 07, 1993

STERILE SUTURE REMOVAL KIT

General & Plastic Surgery · 256d

Cleared Jun 07, 1993

TPN TRAY (STERILE)

General & Plastic Surgery · 256d

Cleared Apr 26, 1993

PREP SHAVE KIT (NON-STERILE)

General & Plastic Surgery · 214d

Cleared Sep 10, 1990

CUSTOMED ARTHROSCOPY PACK

General & Plastic Surgery · 70d

Cleared Sep 10, 1990

CUSTOMED ORTHOPEDIC II

General & Plastic Surgery · 70d

Cleared Aug 29, 1990

CUSTOMED HIP PACT

General & Plastic Surgery · 35d