510(k) K071385 ยท MLR Sterilizer, Chemical
STERRAD 100NX STERILIZER
| Applicant | Advanced Sterilization Products, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 29, 2007 |
| Received | May 18, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071385
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2013 | Advanced Sterilization Products STERRAD 100NX, Product Code: 10104
The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | None listed |
| Oct 22, 2013 | Advanced Sterilization Products STERRAD 100NX Cassettes
The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | None listed |
| Sep 10, 2013 | Advanced Sterilization Products STERRAD 100NX Cassettes, Product Code: 10144
The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | None listed |
| Mar 30, 2013 | Advanced Sterilization Products STERRAD 100NX Sterilization System, P/N 10104
Product Usage:
The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate Terminated |
MLR | None listed |
| Aug 8, 2008 | Advanced Sterilization Products STERRAD 100NX Sterilizer, Product Code 10104
Used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.