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Spark™ TruColor™

METREX RESEARCH, LLC · Model 910181-32 · UDI-DI 00615375014189

EBA
10
510(k) clearances
15
Adverse events
5
Recalls
45
Facilities

Description

Spark™ TruColor™ headlight system - International, Type G plug

Recalls

DateFirmReason
2025-07-03Orascoptic Surgical AcuityDue to complaints, loupe nose pads containing nickel may cause an allergic reaction.
2025-07-03Orascoptic Surgical AcuityDue to complaints, loupe nose pads containing nickel may cause an allergic reaction.
2025-07-03Orascoptic Surgical AcuityDue to complaints, loupe nose pads containing nickel may cause an allergic reaction.
2025-07-03Orascoptic Surgical AcuityDue to complaints, loupe nose pads containing nickel may cause an allergic reaction.
2011-11-17Kerr CorporationThe firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in the control board electronics that may cause some Freedom Cord

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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.