Getinge USA Inc
FDA Regulatory Profile
Getinge USA Inc appears in FDA public data with 2 recalls, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1994-2013, Class II) was initiated on August 2, 2013. Its most recent 510(k) clearance was granted on April 7, 2005.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 4
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1994-2013 | Class II | Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 | August 2, 2013 |
| Z-2079-2012 | Class II | Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermedi | May 25, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K050664 | SPOR-TEST PA BIOLOGICAL INDICATOR KIT | April 7, 2005 |
| K032723 | BIOSIGN STEAM-24 BIOLOGICAL INDICATOR | October 1, 2003 |
| K031647 | BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | July 29, 2003 |
| K031259 | MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER | May 12, 2003 |