Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Bio-Med Devices with 14 510(k) clearances. The most recent is a 510(k) clearance dated Mar 17, 2022: OxyMinder.
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.
| Mar 17, 2022 | OxyMinderK213948 · CCL | 510(k) clearances |
| Jul 20, 2018 | TV-100K173973 · CBK | 510(k) clearances |
| Sep 19, 1995 | CROSSVENT-4 VENTILATORK942938 · CBK | 510(k) clearances |
| Feb 12, 1990 | IC-2A MRI ADULT/PEDIATRIC VENTILATORK896380 · CBK | 510(k) clearances |
| Feb 12, 1990 | MVP-10 MRI INFANT VENTILATORK896381 · CBK | 510(k) clearances |
| Jan 22, 1988 | CBG CUFF MANOMETERK873614 · BSK | 510(k) clearances |
| Jun 5, 1987 | M-1 PRESSURE MONITORK871336 · CAP | 510(k) clearances |
| Jun 5, 1987 | M-2 OXYGEN/TEMPERATURE MONITORK871337 · CCL | 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
