PHARMA-PLAST NEEDLE— 510(k) K852442

Substantially Equivalent

Pharma-Plast USA, Inc.

FDA 510(k) clearance K852442 for PHARMA-PLAST NEEDLE, Substantially Equivalent on 1985-09-20. Applicant: Pharma-Plast USA, Inc..

Clearance details

Applicant: Pharma-Plast USA, Inc.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1985-06-10
Decision date: 1985-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada H3a 2n4, CA

Download summary PDF View on FDA.gov ↗

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.