STRAP WEDGE— 510(k) K963526

Substantially Equivalent

Alimed, Inc.

FDA 510(k) clearance K963526 for STRAP WEDGE, Substantially Equivalent on 1996-10-28. Applicant: Alimed, Inc..

Clearance details

Applicant: Alimed, Inc.
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 1996-09-04
Decision date: 1996-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dedham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMQ

product code FMQ

Death: 8
Total: 8

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.