ClearanceBrief
Panels › Cardiovascular

Cardiovascular devices

304 product codes reviewed by the Cardiovascular panel. 19,244 510(k) clearances and 6,943 recalls in the FDA data, 81% of those recalls name a 510(k).

415510(k)s in 12 months
469recalls in 12 months
5,607recalls that name a 510(k)

Active product codes, Class I

CodeDeviceClass510(k)s, 12 moRecalls, 12 mo
MWSStabilizer, Heart104

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