THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS— 510(k) K955282

Substantially Equivalent

Thermogenesis Corp.

FDA 510(k) clearance K955282 for THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS, Substantially Equivalent on 1996-05-06. Applicant: Thermogenesis Corp..

Clearance details

Applicant: Thermogenesis Corp.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1995-11-16
Decision date: 1996-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Cordova, 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.