Company ยท US
Bioventus, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2026. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (1 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 |
|---|---|---|---|
| Aug 26, 2026 | K253877 | StimTrial Neuromodulation System Bioventus, LLC | GZF |
| Jul 16, 2025 | K243782 | StimTrial Neuromodulation System Bioventus, LLC | GZF |
| Jul 3, 2025 | K243678 | TalisMann Neuromodulation System Bioventus, LLC | GZF |
| Jun 25, 2024 | K233368 | Allograft Delivery Device (OFAC-C) Bioventus, LLC | FMF |
| Dec 5, 2023 | K233490 | SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty Bioventus, LLC | MQV |
| Jun 18, 2020 | K193513 | SIGNAFUSE Bioactive Bone Graft Bioventus | MQV |
| Feb 13, 2017 | K162860 | MCS Bone Graft Bioventus, LLC | MQV |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2020 | Bioventus, LLC EXOGEN Ultrasound Coupling Gel Terminated |
LOF | None listed |
| Feb 13, 2019 | Bioventus, LLC BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names Terminated |
MQV | K132071 |