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Splint LT Kit
Mirrorme3d, LLC · Model MSTL · UDI-DI 00860008704191
EPP
Prescription
10
510(k) clearances
19
Adverse events
2
Recalls
38
Facilities
Description
Patient specific, 3D printed, single use postoperative nasal splints to control edema based a patient’s treatment plan. RX only, non-diagnostic.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-02-21 | Medtronic Xomed, Inc. | Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF 1528116 (sm), 152812 |
| 2011-02-21 | Medtronic Xomed, Inc. | Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF 1528116 (sm), 152812 |
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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.
