Medical Device Manufacturer · US , Stamford , CT

American White Cross, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1985

Recent clearances: ULTRAFERA WOUND DRESSING, AIR MAX EXTERNAL NASAL DILATOR STRIP

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - American White Cross, Inc. General & Plastic Surgery ✕

9 devices

1-9 of 9

Cleared Feb 06, 1997

ULTRAFERA WOUND DRESSING

General & Plastic Surgery · 80d

Cleared Jan 31, 1990

AWC BUTTERFLY WOUND CLOSURES

General & Plastic Surgery · 187d

Cleared Jan 13, 1986

WHITE CROSS STERILE PAD 4IN. X 4IN.

General & Plastic Surgery · 41d

Cleared Sep 05, 1985

DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ

General & Plastic Surgery · 10d

Cleared Aug 21, 1985

NON-ADHERA ADHESIVE PAD 3X4

General & Plastic Surgery · 12d

Cleared Jul 29, 1985

EXTRA LARGE ADHESIVE STRIPS

General & Plastic Surgery · 53d

Cleared Jul 29, 1985

NON-ADHERENT PAD

General & Plastic Surgery · 53d

Cleared Jul 26, 1985

TRICOT ADHESIVE BANDAGE

General & Plastic Surgery · 46d

Cleared Mar 11, 1985

3 X 4 NON-ADHERENT PAD

General & Plastic Surgery · 24d