510(k) K150882 ยท HCF Instrument, Ligature Passing And Knot Tying
Edwards Suture Fastening System
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 16, 2015 |
| Received | Apr 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150882
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 9, 2016 | Mindray DS USA, Inc. dba Mindray North America Panorama Patient Monitoring Network
Mindray DS USA
The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monito Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.