MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA— 510(k) K845021

Substantially Equivalent

Medline Industries, Inc.

FDA 510(k) clearance K845021 for MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA, Substantially Equivalent on 1985-05-20. Applicant: Medline Industries, Inc..

Clearance details

Applicant: Medline Industries, Inc.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1984-12-27
Decision date: 1985-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.