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Brasseler USA
Peter Brasseler Holdings, LLC · Model 5029549U0 · UDI-DI 00887919933342
4
510(k) clearances
10
Adverse events
3
Recalls
60
Facilities
Description
VE4.0TTL-SFGRAY LOUPE
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.