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HIGH RESOLUTION BINOCULAR LOUPES SET
SONTEC INSTRUMENTS, INC. · Model C-000.32.867 · UDI-DI 00192896071483
FSP
Prescription
4
510(k) clearances
10
Adverse events
3
Recalls
62
Facilities
Description
HIGH RESOLUTION BINOCULAR LOUPES ON PROFESSIONAL L HEADBAND WITHOUT S-GUARD SET
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.