FDA Device Intelligence
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Gauze / Sponge,Nonresorbable For External Use

FDA product code NAB · Class 1 · General, Plastic Surgery

3,243
Registered devices
271
Adverse events
6
Recalls
88
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2020-11-05Medline Industries IncRevMedX Trauma Dressing is being recalled due to package seal integrity.
2018-12-27Cardinal Health 200, LLCCurity All Purpose Sponges were not sterilized and distributed
2018-10-16ASO, LLCPotential that gauze pads may not be fully sterilized
2015-08-12Revmedx IncThe XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked a
2012-05-14Hartmann USA, IncMicro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
2012-05-14Hartmann USA, IncMicro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.