K894372

Substantially Equivalent

NIPRO NEEDLE HOLDER

Applicant: Pharma-Plast USA, Inc.
Product code: FMI
Advisory panel: General Hospital
Date received: 1989-07-17
Decision date: 1989-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

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.