Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Arc Medical with 6 510(k) clearances and 1 device recall. The most recent is a device recall dated Feb 19, 2015: ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in….
| Feb 19, 2015 | ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.Class III · Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly. | Device recalls |
| Jul 27, 2009 | THERMOFLO HCH, THERMOFLO FILTERK090738 · CAH | 510(k) clearances |
| Apr 13, 2007 | FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)K063125 · CAH | 510(k) clearances |
| Dec 20, 2001 | FILTERFLO HK011212 · CAH | 510(k) clearances |
| Aug 14, 1998 | CIRCUIT GUARDK982239 · CAH | 510(k) clearances |
| Mar 28, 1995 | EDDK924997 · BTR | 510(k) clearances |
| Apr 7, 1993 | XTEND CIRCUITS (TM)K924627 · CAI | 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
