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System, Laser, Transmyocardial Revascularization

FDA product code MNO · Class 3 · Unknown

5
Registered devices
154
Adverse events
1
Recalls
0
510(k) clearances

Devices with this code

The Heart Laser Disposable TMR kit — Novadaq Technologies IncCardioGenesis — Artivion, Inc.CardioGenesis — Artivion, Inc.n.a. — Karl Storz GmbH & Co. KGCardioGenesis — Artivion, Inc.

Recent recalls

DateFirmReason
2011-05-01Cardiogenesis CorporationFollowing acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.