Hartmann USA, Inc
Medical device manufacturer in Rock Hill, SC.
1510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K242758 | Atrauman® AgFRO · Traditional | 12/09/2024SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1858-2012 Class II | Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case…Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and… | 05/14/2012Terminated |
| Z-1857-2012 Class II | Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total…Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and… | 05/14/2012Terminated |
| Z-1866-2011 | HydroHydrofilm is for use as a post-operative and primary dressing to protect against…Misbranded; the expiry date on the primary packing incorrectly indicates 2010-10, instead of 2015-10.… | 02/11/2011Terminated |