ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO. SYRINGE— 510(k) K871007

Substantially Equivalent

Habley Medical Technology Corp.

FDA 510(k) clearance K871007 for ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO. SYRINGE, Substantially Equivalent on 1987-04-30. Applicant: Habley Medical Technology Corp..

Clearance details

Applicant: Habley Medical Technology Corp.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1987-03-13
Decision date: 1987-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguana Hills, CA, 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.