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Microtome, Cryostat

FDA product code IDP · Class 1 · Pathology

85
Registered devices
40
Adverse events
10
Recalls
1
510(k) clearances

Devices with this code

Epredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITED6250 Cryostat Microtome — Dakewe (Shenzhen) Medical Equipment Co., Ltd.Tissue-Tek® Cryo3® — SAKURA FINETEK U.S.A., INC.Epredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITED

Recent recalls

DateFirmReason
2025-01-30LEICA BIOSYSTEMS NUSSLOCH GMBHFirm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
2024-09-04LEICA BIOSYSTEMS NUSSLOCH GMBHAs part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezi
2024-09-04LEICA BIOSYSTEMS NUSSLOCH GMBHAs part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezi
2024-09-04LEICA BIOSYSTEMS NUSSLOCH GMBHAs part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezi
2024-09-04LEICA BIOSYSTEMS NUSSLOCH GMBHAs part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezi
2024-09-04LEICA BIOSYSTEMS NUSSLOCH GMBHAs part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezi
2024-09-04LEICA BIOSYSTEMS NUSSLOCH GMBHAs part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezi
2019-05-03Leica Microsystems, Inc.The current labelling does not include any specific warning about usage of flammable freezing sprays. Such flammable freezing sprays can potentially ignite and
2010-09-23Thermo Fisher ScientificThrough internal quality review, firm determined the need to conduct a more comprehensive system validation to support the claim of complete bacterial, fungal a
2010-09-23Thermo Fisher ScientificThrough internal quality review, firm determined the need to conduct a more comprehensive system validation to support the claim of complete bacterial, fungal a

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.