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VISIUSeye
IMRIS Imaging, Inc. · Model VISIUSeye iMRI 1.5T A and 3TS · UDI-DI 00857534006288
FTY
Prescription
10
510(k) clearances
435
Adverse events
5
Recalls
398
Facilities
Description
VISIUSeye iMRI 1.5T A and 3TS, 117534-000
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-03-05 | SpineFrontier, Inc. | The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use |
| 2010-10-22 | Lemaitre Vascular, Inc. | Box label (Top Part). Lot and Expiration Date information were switched. |
| 2010-10-22 | Lemaitre Vascular, Inc. | Box label (Top Part). Lot and Expiration Date information were switched. |
| 2010-10-22 | Lemaitre Vascular, Inc. | Box label (Top Part). Lot and Expiration Date information were switched. |
| 2010-10-22 | Lemaitre Vascular, Inc. | Box label (Top Part). Lot and Expiration Date information were switched. |
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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.
