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 Miach Orthopaedics with 2 510(k) clearances, 2 device recalls and 1 warning letter. The most recent is a 510(k) clearance dated Jan 13, 2026: BEAR® (Bridge-Enhanced ACL Restoration) Implant.
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.
| Jan 13, 2026 | BEAR® (Bridge-Enhanced ACL Restoration) ImplantK251214 · QNI | 510(k) clearances |
| Dec 31, 2025 | BEAR Implant. Model Number: 1000.Class II · Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect | Device recalls |
| Aug 19, 2025 | Warning letter: Sterility assurance, Process validation, CAPACDRH | Warning letters |
| Mar 6, 2025 | BEAR® (Bridge-Enhanced ACL Restoration) ImplantK243578 · QNI | 510(k) clearances |
| Feb 2, 2023 | BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;Class II · The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only | Device recalls |
| Dec 16, 2020 | BEAR (Bridge-Enhanced ACL Repair) ImplantDEN200035 · QNI | 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
