HYDRO-S WOUND GEL— 510(k) K942419

Substantially Equivalent

Hymedix Intl., Inc.

FDA 510(k) clearance K942419 for HYDRO-S WOUND GEL, Substantially Equivalent on 1994-08-05. Applicant: Hymedix Intl., Inc..

Clearance details

Applicant: Hymedix Intl., Inc.
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1994-05-20
Decision date: 1994-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, NJ, US

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Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

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.