DeviceClearance

Heartware, Inc.

Heartware, Inc. holds 1 FDA 510(k) medical device clearance, cleared in 1997, with 72 FDA device recalls on record.

Top product codes for Heartware, Inc.

FDA recalls by Heartware, Inc.

10 most recent of 72

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

Recent clearances by Heartware, Inc.

Data sourced from openFDA. This site is unofficial and independent of the FDA.