Company ยท US
Smith and Nephew, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2023. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 11, 2023 | K222501 | Regeneten Bioinductive Implant Smith and Nephew, Inc. | OWY |
| Oct 20, 2022 | K221740 | SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UN Smith and Nephew, Inc. | GCJ |
| Aug 23, 2019 | K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head Smith and Nephew, Inc. | GCJ |
| Mar 12, 2019 | K183232 | Double ENDOBUTTON Fixation Device Smith and Nephew, Inc. | HTN |
| Sep 28, 2018 | K181746 | MICRORAPTOR Knotless Suture Anchor Smith and Nephew, Inc. | MAI |
| May 30, 2018 | K180361 | MICRORAPTOR REGENESORB Suture Anchor Smith and Nephew, Inc. | MAI |
| Dec 7, 2016 | K163034 | SUTUREFIX Curved Suture Anchor Smith and Nephew, Inc. | MBI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||