Company
LEICA BIOSYSTEMS NUSSLOCH GMBH
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| 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 |
| Aug 7, 2024 | LEICA BIOSYSTEMS NUSSLOCH GMBH Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station. Open, Classified |
IDW | None listed |
| Jun 4, 2024 | LEICA BIOSYSTEMS NUSSLOCH GMBH Leica HistoCore PEGASUS Tissue Processor, REF 14048858005. Open, Classified |
IEO | None listed |
| Dec 20, 2023 | LEICA BIOSYSTEMS NUSSLOCH GMBH Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) Open, Classified |
IEO | None listed |