Reichert, Inc.
Reichert, Inc. holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2024, with 3 FDA device recalls on record.
Top product codes for Reichert, Inc.
FDA recalls by Reichert, Inc.
- Z-1501-2025 — Phoroptor VRx Digital Refraction System Model Numbers: 16242
- Z-1500-2025 — Phoroptor VRx Digital Refraction System Model Numbers: 16241
- Z-2512-2023 — PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 [Model 16241 is the base model. Model 16242 includes an additional prism feature used for the measurement of ocular deviation in patients with latent or manifest strabismus].
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Reichert, Inc.
- K233516 — Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
- K141954 — XCEL 455 SLIT LAMP
- K081756 — OCULAR RESPONSE ANALYZER
- K071839 — SOCT COPERNICUS, MODEL 15205
- K070534 — MODIFICATION TO: OCU-FILM TIP COVER
- K063750 — XCEL 255 SLIT LAMP
- K061330 — PSL PORTABLE SLIT LAMP
- K042831 — ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER)
- K032799 — NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.