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DIGITAL MEDICAL SCOPE
NIDEK CO.,LTD. · Model DS-10D · UDI-DI 04987669101025
FSP
Prescription
4
510(k) clearances
10
Adverse events
3
Recalls
61
Facilities
Description
DS-10D is a digital hand-held dermatoscope used to record digital photographs and video of the human skin.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-03 | Orascoptic Surgical Acuity | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. |
| 2025-07-03 | Orascoptic Surgical Acuity | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. |
| 2012-04-10 | Kerr Corporation | The 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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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.