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Cadwell Guardian

CADWELL INDUSTRIES, INC. · Model 199334-000-008 · UDI-DI 00840067103555

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510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

Amplifier Pod Cable, 8 meter

Recalls

Date	Firm	Reason
2018-07-02	Hudson Scientific LLC	The device and its accessories may not have been manufactured according to current Good Manufacturing Practices. In addition, the firm has received three complaints regarding elect
2015-11-23	ZYTO Technologies, Inc.	ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.
2015-11-23	ZYTO Technologies, Inc.	ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.

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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.