FDA applicant
Carl Zeiss Meditec Cataract Technology, Inc.
FDA records 7 decisions for Carl Zeiss Meditec Cataract Technology, Inc. (Reno, NV) from 2019 to 2025: 7 510(k) clearances. All are in product code HQC (Unit, Phacofragmentation). Since 2016 its 510(k)s took a median of 261 days from receipt to decision, against 245 for FDA’s reviews in the same codes and years. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Carl Zeiss Meditec Cataract Technology, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Carl Zeiss Meditec Cataract…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Carl”
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