inforMED
KRHClass IIImplant

Ring, Annuloplasty

Cardiovascular · 21 CFR 870.3800

MDR events9,673All time
Recalls0All time
Registered firms108Currently listed
510(k) clearances75All time

Recent MDR events

9,673 adverse event reports on file

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Event type breakdown

Injury8,517
Death780
Malfunction206
Other148
Unspecified22

Most-reported manufacturers

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Edwards Lifesciences4,801Medtronic Heart Valves Division2,453Baxter Healthcare Corp.527Medtronic Heart Valve Division392Medtronic Mexico S. De R.l. De Cv269Medtronic Mexico234Abbott Medical142Heart Valves Santa Ana111

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

108 firms currently registered for this product code

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510(k) clearances

75 clearances for this product code

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