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BR Surgical, LLC

BR Surgical, LLC · Model BR66-28114 · UDI-DI 00840183501945

GCC
5
510(k) clearances
73
Adverse events (10 deaths)
5
Recalls
101
Facilities

Description

WALTHER Female Urethral Dilator, Ø 14 FR, 5"

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.