FRANTZ MEDICAL SHARPS COLLECTOR— 510(k) K884589

Substantially Equivalent

Franklin Medical USA, Inc.

FDA 510(k) clearance K884589 for FRANTZ MEDICAL SHARPS COLLECTOR, Substantially Equivalent on 1988-12-09. Applicant: Franklin Medical USA, Inc..

Clearance details

Applicant: Franklin Medical USA, Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1988-11-03
Decision date: 1988-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.