Company ยท US
Getinge USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2005. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 7, 2005 | K050664 | SPOR-TEST PA BIOLOGICAL INDICATOR KIT Getinge USA, Inc. | FRC |
| Oct 1, 2003 | K032723 | BIOSIGN STEAM-24 BIOLOGICAL INDICATOR Getinge USA, Inc. | FRC |
| Jul 29, 2003 | K031647 | BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR Getinge USA, Inc. | JOJ |
| May 12, 2003 | K031259 | MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER Getinge USA, Inc. | FLE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2013 | Getinge USA Inc Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 1462 Terminated |
FRC | K093794 |
| Jul 26, 2012 | Getinge USA Inc Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, s Terminated |
MEC | None listed |