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Gyrus ACMI
Gyrus ACMI, LLC · Model 005-5-101 · UDI-DI 00821925037014
HQP
Prescription
1
510(k) clearances
106
Adverse events
3
Recalls
20
Facilities
Description
OPHTHALMIC CAUTERY, FINE TIP, STERILE LOW TEMPERATURE (10/PK)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-07-19 | Beaver Visitec | A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may c |
| 2004-06-29 | Aaron Medical Industries, Inc. | The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation. |
| 2004-06-29 | Aaron Medical Industries, Inc. | The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation. |
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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.