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 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Ohio Medical Corporation with 4 device recalls and 2 510(k) clearances. The most recent is a device recall dated May 8, 2025: GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S.
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.
| May 8, 2025 | GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-SClass II · Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to th | Device recalls |
| Nov 16, 2021 | Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac repClass II · Increase in premature device failures | Device recalls |
| Aug 14, 2018 | Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC ThClass II · The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an e | Device recalls |
| Mar 12, 2018 | Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medicaClass II · Final quality control testing was not completed before the devices were distributed.. | Device recalls |
| May 2, 2008 | MOBLVAC W.C.K081185 · BTA | 510(k) clearances |
| Sep 28, 2006 | CARE-E-VAC 3K062610 · BTA | 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
