Atlas FDA

Orascoptic Surgical Acuity

6 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Orascoptic Superior Visualization Custom loupes with Dragonfly frames recall (Z-2440-2025)Orascoptic Surgical Acuity2025-08-26
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames recall (Z-2441-2025)Orascoptic Surgical Acuity2025-08-26
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens clean recall (Z-2442-2025)Orascoptic Surgical Acuity2025-08-26
Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning recall (Z-2443-2025)Orascoptic Surgical Acuity2025-08-26
Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 recall (Z-2444-2025)Orascoptic Surgical Acuity2025-08-26
Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 p recall (Z-2445-2025)Orascoptic Surgical Acuity2025-08-26

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Every clearance here is in the API, with alerts when new ones post.