Home › BIOVENTUS LLC › StimTrial Stimulator Kit

StimTrial Stimulator Kit

BIOVENTUS LLC · Model TS-5000 · UDI-DI 00816986020587

GZF Prescription

510(k) clearances

4,474

Adverse events (16 deaths)

Recalls

Facilities

Recalls

Date	Firm	Reason
2024-06-03	Nalu 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
2020-07-15	Stimwave Technologies Inc	The product contains a non-functional component not referenced in product labeling.
2020-07-15	Stimwave Technologies Inc	The product contains a non-functional component not referenced in product labeling.
2020-07-15	Stimwave Technologies Inc	The product contains a non-functional component not referenced in product labeling.
2020-07-15	Stimwave Technologies Inc	The product contains a non-functional component not referenced in product labeling.
2020-07-15	Stimwave Technologies Inc	The product contains a non-functional component not referenced in product labeling.
2020-07-15	Stimwave Technologies Inc	The product contains a non-functional component not referenced in product labeling.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.