Microtome, Cryostat
Regulation 864.3010
0510(k)s in 12 months (1 all time)
0recalls in 12 months (10 all time)
0recalls that name a 510(k)
Top companies in IDP
| Company | 510(k)s | Recalls |
|---|---|---|
| LEICA BIOSYSTEMS NUSSLOCH GMBH | 0 | 7 |
| Thermo Fisher Scientific | 0 | 2 |
| Exakt Medical Instruments, Inc. | 1 | 0 |
| Leica Microsystems, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2025 | LEICA BIOSYSTEMS NUSSLOCH GMBH Brand Name: Leica Biosystems Cryostats
Product Name: CM1950
Model/Catalog Number: 1491950C4US
Software Version: firmware V3.01 Open, Classified |
IDP | None listed |
| Oct 15, 2024 | LEICA BIOSYSTEMS NUSSLOCH GMBH Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples Open, Classified |
IDP | None listed |
| Oct 15, 2024 | LEICA BIOSYSTEMS NUSSLOCH GMBH Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples Open, Classified |
IDP | None listed |
| Oct 15, 2024 | LEICA BIOSYSTEMS NUSSLOCH GMBH Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples Open, Classified |
IDP | None listed |
| Oct 15, 2024 | LEICA BIOSYSTEMS NUSSLOCH GMBH Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148,
b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples Open, Classified |
IDP | None listed |
| Oct 15, 2024 | LEICA BIOSYSTEMS NUSSLOCH GMBH Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples Open, Classified |
IDP | None listed |
| Oct 15, 2024 | LEICA BIOSYSTEMS NUSSLOCH GMBH Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples Open, Classified |
IDP | None listed |
| Jun 4, 2019 | Leica Microsystems, Inc. Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications. Terminated |
IDP | None listed |
| Mar 21, 2011 | Thermo Fisher Scientific Thermo Scientific HM 560 Cold Disinfection Cryostat, Microm International GmbH, Waldorf, Germany
Tissue processing equipment used to prepare human tissue specimens for diagnostic histological examina Terminated |
IDP | None listed |
| Mar 21, 2011 | Thermo Fisher Scientific Thermo Scientific HM 550 Cold Disinfection Cryostat, Microm International GmbH, Waldorf, Germany
Tissue processing equipment used to prepare human tissue specimens for diagnostic histological examin Terminated |
IDP | None listed |
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