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Nalu Medical, Inc.

NALU MEDICAL, INC. · Model 23002-045-US · UDI-DI 00812537032016

GZFGZB Prescription
10
510(k) clearances
4,474
Adverse events (16 deaths)
7
Recalls
27
Facilities

Description

Stylet (Bent, 45 cm)

Recalls

DateFirmReason
2024-06-03Nalu Medical, Inc.Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the The
2020-07-15Stimwave Technologies IncThe product contains a non-functional component not referenced in product labeling.
2020-07-15Stimwave Technologies IncThe product contains a non-functional component not referenced in product labeling.
2020-07-15Stimwave Technologies IncThe product contains a non-functional component not referenced in product labeling.
2020-07-15Stimwave Technologies IncThe product contains a non-functional component not referenced in product labeling.
2020-07-15Stimwave Technologies IncThe product contains a non-functional component not referenced in product labeling.
2020-07-15Stimwave Technologies IncThe product contains a non-functional component not referenced in product labeling.

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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.