Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Bioventus and its 2 subsidiaries with 39 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Aug 26, 2026: StimTrial Neuromodulation System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Bioventus and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 26, 2026 | StimTrial Neuromodulation SystemK253877 · GZF | 510(k) clearances |
| Jul 30, 2026 | neXus Ultrasonic Surgical Aspirator SystemK261448 · LFL | 510(k) clearances |
| Jul 16, 2025 | StimTrial Neuromodulation SystemK243782 · GZF | 510(k) clearances |
| Jul 3, 2025 | TalisMann Neuromodulation SystemK243678 · GZF | 510(k) clearances |
| Jun 25, 2024 | Allograft Delivery Device (OFAC-C)K233368 · FMF | 510(k) clearances |
| Dec 5, 2023 | SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyK233490 · MQV | 510(k) clearances |
| Jun 23, 2023 | neXus Ultrasonic Surgical Aspirator SystemK231117 · LFL | 510(k) clearances |
| Jul 28, 2022 | neXus Ultrasonic Surgical Aspirator SystemK221235 · LFL | 510(k) clearances |
| Dec 17, 2020 | EXOGEN Ultrasound Coupling GelClass II · Product may contain white particulates that are microbial in nature. | Device recalls |
| Feb 13, 2019 | BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to theClass II · The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging fai | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
