Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list BMC Medical with 7 510(k) clearances, 1 device recall and 1 warning letter. The most recent is a 510(k) clearance dated Aug 14, 2026: Portable Oxygen Concentrator (PO1 5B, PO1 6B).
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.
| Aug 14, 2026 | Portable Oxygen Concentrator (PO1 5B, PO1 6B)K260171 · CAW | 510(k) clearances |
| Jul 15, 2026 | BMC/REACTHEALTH Luna G3 APAP REF LG 3600Class I · Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse | Device recalls |
| May 20, 2026 | Warning letter: 510(k) requiredCDRH | Warning letters |
| Apr 29, 2026 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)K253166 · BZD | 510(k) clearances |
| Jan 15, 2025 | Respiration Data Management Software (PAP Link PC)K242935 · BZD | 510(k) clearances |
| Dec 5, 2022 | BPAP SystemK213169 · MNS | 510(k) clearances |
| Mar 9, 2022 | Auto CPAP SystemK211155 · BZD | 510(k) clearances |
| Sep 5, 2017 | Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)K163464 · BZD | 510(k) clearances |
| Apr 23, 2014 | NASAL MASK, NASAL MASK, FULL FACE MASKK133009 · BZD | 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
