MEGA MYELOGRAM KIT— 510(k) K913141

Substantially Equivalent

Megadyne Medical Products, Inc.

FDA 510(k) clearance K913141 for MEGA MYELOGRAM KIT, Substantially Equivalent on 1991-10-17. Applicant: Megadyne Medical Products, Inc..

Clearance details

Applicant: Megadyne Medical Products, Inc.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1991-07-16
Decision date: 1991-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

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Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.