Leica Microsystems, Inc.
Leica Microsystems, Inc. holds FDA 510(k) medical device clearances, first cleared 1999, most recent 2006, with 40 FDA device recalls on record.
Top product codes for Leica Microsystems, Inc.
FDA recalls by Leica Microsystems, Inc.
10 most recent of 40- Z-0475-2023 — Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
- Z-0477-2023 — Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
- Z-0476-2023 — Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
- Z-1848-2022 — Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
- Z-1851-2022 — Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
- Z-1849-2022 — Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
- Z-1850-2022 — Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
- Z-0412-2022 — Leica Microsystems M220 F12 Microscope Systems
- Z-2481-2021 — BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
- Z-2399-2020 — Leica ARveo and M530 OH6 microscope systems.
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 Leica Microsystems, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.