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Byrd
Cook Vandergrift Inc. · Model G20535 · UDI-DI 00827002205352
GCC
Prescription
5
510(k) clearances
74
Adverse events (10 deaths)
5
Recalls
100
Facilities
Description
10.0 Fr Byrd Dilator Sheath Set (B) Extra Long Polypropylene
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-07-31 | DePuy Spine, Inc. | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
| 2013-07-31 | DePuy Spine, Inc. | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
| 2013-07-31 | DePuy Spine, Inc. | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
| 2013-07-31 | DePuy Spine, Inc. | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
| 2013-07-31 | DePuy Spine, Inc. | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
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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.