Hartmann USA, Inc.
Hartmann USA, Inc. holds FDA 510(k) medical device clearance, cleared in 2024, with 2 FDA device recalls on record.
Top product codes for Hartmann USA, Inc.
FDA recalls by Hartmann USA, Inc.
- Z-1857-2012 — Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing
- Z-1858-2012 — Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Hartmann USA, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.