IMPLANT LOCATION SOFTWARE-T— 510(k) K070713

Substantially Equivalent

Tactile Technologies, Ltd.

FDA 510(k) clearance K070713 for IMPLANT LOCATION SOFTWARE-T, Substantially Equivalent on 2007-05-02. Applicant: Tactile Technologies, Ltd..

Clearance details

Applicant: Tactile Technologies, Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2007-03-14
Decision date: 2007-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rechovot, IL

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.