Carl Zeiss Meditec, AG
Carl Zeiss Meditec, AG holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2026, with 11 FDA device recalls on record.
Top product codes for Carl Zeiss Meditec, AG
FDA recalls by Carl Zeiss Meditec, AG
10 most recent of 11- Z-2649-2026 — Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
- Z-1007-2022 — ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
- Z-1133-2021 — IOLMaster 700
- Z-0613-2021 — Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.
- Z-0614-2021 — Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses and contact lenses.
- Z-0108-2019 — Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
- Z-0001-2018 — Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
- Z-0358-2016 — IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
- Z-0357-2016 — IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.
- Z-1049-2015 — FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1) Ophthalmic image management system.
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 Carl Zeiss Meditec, AG
- K260694 — ZEISS CLINIC 360
- K241174 — INTRABEAM (700) +1 more
- K233911 — VISULAS combi
- K240215 — BLUE 400; BLUE 400 S
- K233421 — RESCAN 700
- K232944 — CALLISTO eye
- K232159 — QEVO System
- K231676 — CALLISTO eye
- K230858 — QUATERA 700
- K213527 — FORUM
- K211346 — BLUE 400
- K212241 — QUATERA 700
- K211156 — CONVIVO In Vivo Pathology Suite
- K193376 — Visalis V500, Visalis S500
- K181682 — VISULAS green
- K180229 — RESCAN 700, CALLISTO eye
- K181116 — CONVIVO
- K173771 — IOLMaster 700
- K180858 — CALLISTO eye
- K180839 — AT 030
- K170667 — QEVO System with KINEVO 900
- K162991 — YELLOW 560 Fluorescence Module
- K170638 — Retina Workplace
- K162684 — SL 220
- K170171 — IOLMaster 700
- K161607 — VISULUX
- K162568 — INTRABEAM 600
- K150467 — Retina Workplace
- K141844 — RESCAN 700, CALLISTO EYE
- K141297 — FORUM GLAUCOMA WORKPLACE
- K141068 — ZEISS CATARACT SUITE MARKERLESS
- K133217 — CIRRUS PHOTO
- K133476 — SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
- K130648 — FORUM GLAUCOMA WORKPLACE
- K122418 — IOLMASTER 500
- K123464 — CALLISTO EYE
- K122938 — FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
- K103056 — VISULAS TRION LASER SYSTEM WITH THE VITE OPTION
- K101182 — IOLMASTER 500
- K100253 — VISUMAX LASER KERATOME
- K100035 — MODEL VISULAS 532S LASER WITH THE VITE OPTION
- K072514 — VISULAS TRION
- K062314 — HORUS LASER KERATOME
- K052268 — VISUCAM PRO NM
- K043222 — VISCUCAM C DIGITAL CAMERA
- K042139 — VISULAS YAG III
Data sourced from openFDA. This site is unofficial and independent of the FDA.