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HNM Medical

HNM STAINLESS, LLC. · Model HNM-1-52-3633 · UDI-DI 00842962127599

GCC
5
510(k) clearances
75
Adverse events (10 deaths)
5
Recalls
100
Facilities

Description

PRATT UTERINE DILATOR, DOUBLE ENDED, 33FR/35FR

Recalls

DateFirmReason
2013-07-31DePuy Spine, Inc.Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
2013-07-31DePuy Spine, Inc.Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
2013-07-31DePuy Spine, Inc.Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
2013-07-31DePuy Spine, Inc.Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
2013-07-31DePuy 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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Data 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.