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.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Engineered Medical Systems with 24 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Nov 16, 2022: Endoscopy Oxygen Mask.
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.
| Nov 16, 2022 | Endoscopy Oxygen MaskK220533 · CCK | 510(k) clearances |
| Sep 12, 2011 | Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for variouClass I · The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates. | Device recalls |
| Apr 20, 2007 | TALKING TRACHK062104 · BTO | 510(k) clearances |
| Dec 1, 2003 | MULTI-STRAP FULL FACE MASKK023683 · BZD | 510(k) clearances |
| Jul 30, 2002 | TRACH VOXK013728 · JOH | 510(k) clearances |
| Apr 19, 2002 | EMS ELECTROSTATIC FLITER AND HME COMBINATIONK013122 · CAH | 510(k) clearances |
| Mar 14, 2002 | EMS HEPA FILTER AND HME COMBINATIONSK013089 · CAH | 510(k) clearances |
| Mar 14, 2002 | EMS PULMONARY FUNCTION TESTING FILTERK013123 · BZG | 510(k) clearances |
| Nov 30, 2000 | DISPOSABLE PRESSURE MONITORK003497 · CAP | 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
