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Karl Storz GmbH & Co. KG · Model TL400 · UDI-DI 04048551425695

MNOGWGFET Prescription
0
510(k) clearances
154
Adverse events (8 deaths)
1
Recalls
1
Facilities

Description

Power LED RUBINA, OPAL1 NIR/ICG

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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Data 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.