Bioventus, LLC
Bioventus, LLC holds FDA 510(k) medical device clearances, first cleared 2017, most recent 2026, with 2 FDA device recalls on record.
Top product codes for Bioventus, LLC
FDA recalls by Bioventus, LLC
- Z-0810-2021 — EXOGEN Ultrasound Coupling Gel
- Z-1148-2019 — BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTEOFUSE and MEDLINE UNITE.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Bioventus, LLC
Data sourced from openFDA. This site is unofficial and independent of the FDA.