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Orion Diagnostics

TIMESCO HEALTHCARE LIMITED · Model 2510.100.50 · UDI-DI 05055382818335

FSP Prescription
4
510(k) clearances
10
Adverse events
3
Recalls
60
Facilities

Description

Orion Std Dermatoscope Xenon C 2.5v

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.
2012-04-10Kerr CorporationThe firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes work according to speci

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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.