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 STERISLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Microtek Medical with 26 510(k) clearances and 22 device recalls. The most recent is a 510(k) clearance dated Sep 16, 2025: Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, ….
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.
| Sep 16, 2025 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)K251676 · LHI | 510(k) clearances |
| Apr 13, 2025 | Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient DrapeClass II · Due to non-sterile products being labeled as sterile | Device recalls |
| Apr 8, 2014 | SURGICAL LIGHT HANDLE COVERK133554 · FTA | 510(k) clearances |
| May 5, 2011 | VENODYNE V810K110358 · JOW | 510(k) clearances |
| Feb 23, 2011 | FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STKK102971 · FYA | 510(k) clearances |
| Jan 25, 2007 | MICROTEK MEDICAL SURGICAL GOWN/TOGAK062899 · FYA | 510(k) clearances |
| May 31, 2006 | MICROTEK MEDICAL WARMING DRAPEK060200 · KKX | 510(k) clearances |
| May 17, 2005 | MICROTEK EQUIPMENT DRAPESK050322 · KKX | 510(k) clearances |
| Nov 27, 2002 | CHILLBUSTERK022903 · DWJ | 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
