Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Orascoptic Surgical Acuity with 6 device recalls. The most recent is a device recall dated Jul 3, 2025: Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cl….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 3, 2025 | Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdrClass II · Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Device recalls |
| Jul 3, 2025 | Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.Class II · Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Device recalls |
| Jul 3, 2025 | Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.Class II · Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Device recalls |
| Jul 3, 2025 | Orascoptic Superior Visualization Custom loupes with Dragonfly framesClass II · Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Device recalls |
| Jul 3, 2025 | Orascoptic Superior Visualization Custom loupes configured with Phantom FramesClass II · Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Device recalls |
| Jul 3, 2025 | Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdrivClass II · Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
