EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)— 510(k) K050495

Substantially Equivalent

Baxter Healthcare Corp., Bioscience

FDA 510(k) clearance K050495 for EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT), Substantially Equivalent on 2005-05-02. Applicant: Baxter Healthcare Corp., Bioscience.

Clearance details

Applicant: Baxter Healthcare Corp., Bioscience
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2005-02-28
Decision date: 2005-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Westlake Village, 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.