Medical device makerLabelled 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 15, 2026, FDA's public records list Synergy Biomedical, LLC with 5 510(k) clearances. The most recent is a 510(k) clearance dated Dec 20, 2024: BioSphere Putty; BioSphere MIS Putty.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 20, 2024 | BioSphere Putty; BioSphere MIS PuttyK241167 · MQV | 510(k) clearances |
| Sep 12, 2018 | BioSphere FlexK173424 · MQV | 510(k) clearances |
| Jan 19, 2018 | BioSphere MIS Putty (BioSphere MIS)K173301 · MQV | 510(k) clearances |
| Jul 16, 2014 | BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CCK140844 · MQV | 510(k) clearances |
| Apr 19, 2013 | BIOSPHERE BIOACTIVE BONE GRAFT PUTTYK122868 · MQV | 510(k) clearances |
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
