Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of PhilipsLabelled by claude-sonnet-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 Healthdyne, Inc. with 35 510(k) clearances. The most recent is a 510(k) clearance dated Sep 21, 1995: PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS).
| Sep 21, 1995 | PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)K950331 · BZD | 510(k) clearances |
| Jul 6, 1994 | ALICEK922106 · OLV | 510(k) clearances |
| May 27, 1994 | H-500 ALLIANCE OXYGEN CONCENTRATORK942357 · CAW | 510(k) clearances |
| Apr 4, 1994 | FLOW SPIROMETERK934502 · BZH | 510(k) clearances |
| Jan 7, 1993 | OH-500 OXYGEN CONCENTRATORK924146 · CAW | 510(k) clearances |
| Dec 1, 1992 | NEBULIZER SYSTEMK922623 · BTI | 510(k) clearances |
| Feb 14, 1991 | DATA RECORDERK910118 · FLL | 510(k) clearances |
| Aug 17, 1990 | MODEL 900S APNEA/HEART MONITORK903287 · BZQ | 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
