Home › Gyrus ACMI, LLC › Gyrus ACMI
Gyrus ACMI
Gyrus ACMI, LLC · Model 70890740 · UDI-DI 00821925037151
EMX
Prescription
10
510(k) clearances
103
Adverse events (2 deaths)
4
Recalls
53
Facilities
Description
Sterile Expandacell Sponge, Wideline Cannulated Nasal Pack, Medium (polyvinyl alcohol sponge) (6/PK)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.