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The Heart Laser Disposable TMR kit
Novadaq Technologies Inc · Model AC00012 · UDI-DI 00860701000101
0
510(k) clearances
154
Adverse events (8 deaths)
1
Recalls
1
Facilities
Description
Sterile disposable kit which includes TMR handpieces, arm drape, cleaning swabs, heart diagram and markers
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-05-01 | Cardiogenesis Corporation | Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.