Is this your brand? Sign in to claim ownership.
Sign in to claim this brandAgilent Technologies Inc.
United States·US-MF-000009385
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 5301, Stevens Creek Blvd., Santa Clara, United States
- Website
- www.agilent.com
- —
- —
- [email protected]
- Phone
- +45 44859756
- PRRC Contact
- Grace Lee
- EUDAMED SRN
- US-MF-000009385
- FDA FEI Number
- 3009189893
- DUNS Number
- —
Catalogue (1184)
Page 24 of 24| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Holter Recorder | K822970 | FDA 510(k) | Class II | Active |
| Zymed Model 1610 | K895208 | FDA 510(k) | Class II | Active |
| Modification To Zymed Telemetry System, Model Easiview | K001308 | FDA 510(k) | Class II | Active |
| Zymed Telemetry Monitor Model T8010 (preliminary) | K924672 | FDA 510(k) | Class II | Active |
| Zymed Holter Scanner Model 2010 | K930806 | FDA 510(k) | Class II | Active |
| 2010 Plus Holter For Windows | K003940 | FDA 510(k) | Class II | Active |
| Quikpage Arrhythmia Report Generator | K841083 | FDA 510(k) | Class II | Active |
| Epoch | EpochRH-SI | EUDAMEDFDA UDI | Class A | Active |
| Synergy H1 | SH1MG-SI | EUDAMEDFDA UDI | Class A | Active |
| 800ts | 800TS-SI | EUDAMEDFDA UDI | Class A | Active |
| GenetiSure Dx Labeling Kit | K1201-64105 | EUDAMEDFDA UDI | Class A | Active |
| GenetiSure Dx Labeling Kit Purification Columns | K1201-64110 | EUDAMEDFDA UDI | Class A | Active |
| Synergy H1 | H1M2FG-SI | EUDAMEDFDA UDI | Class A | Active |
| Synergy H1 | H1MF-SI | EUDAMEDFDA UDI | Class A | Active |
| Synergy HTX | S1L-SI | EUDAMEDFDA UDI | Class A | Active |
| Synergy H1 | SH1M2G-SI | EUDAMEDFDA UDI | Class A | Active |
| GenetiSure Dx Hybridization Kit | K1201-64200 | EUDAMEDFDA UDI | Class A | Active |
| Synergy HTX | S1LFA-SI | EUDAMEDFDA UDI | Class A | Active |
| GenetiSure Dx Wash Buffer 1 | K1201-64305 | EUDAMEDFDA UDI | Class A | Active |
| Synergy H1 | SH1M2FG-SI | EUDAMEDFDA UDI | Class A | Active |
| Synergy HTX | S1A-SI | EUDAMEDFDA UDI | Class A | Active |
| Synergy H1 | H1MFG-SI | EUDAMEDFDA UDI | Class A | Active |
| Synergy H1 | SH1M-SI | EUDAMEDFDA UDI | Class A | Active |
| Synergy HTX | S1LF-SI | EUDAMEDFDA UDI | Class A | Active |
| Synergy H1 | H1M-SI | EUDAMEDFDA UDI | Class A | Active |
| Synergy HTX | S1LFTA-SI | EUDAMEDFDA UDI | Class A | Active |
| Synergy H1 | H1FG-SI | EUDAMEDFDA UDI | Class A | Active |
| Epoch | EpochH-SI | EUDAMEDFDA UDI | Class A | Active |
| Synergy H1 | H1MG-SI | EUDAMEDFDA UDI | Class A | Active |
| 800ts | 800TSUV-SI | EUDAMEDFDA UDI | Class A | Active |
| Synergy H1 | SH1M2-SI | EUDAMEDFDA UDI | Class A | Active |
| 800ts | 800TSQIA | EUDAMEDFDA UDI | Class A | Active |
| Epoch 2 | Epoch2NSC-SI | EUDAMEDFDA UDI | Class A | Active |
| 800ts | 800TSNB-SI | EUDAMEDFDA UDI | Class A | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (5)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 20, 2025 | Z-1544-2025 | — | open, classified | DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline shift, which may lead to false positive/negative results, resulting in diagnosis delay, and may lead to delayed treatment of a treatable genetic disorder. |
| Apr 2, 2024 | Z-1919-2024 | — | open, classified | There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury. |
| May 20, 2022 | Z-1384-2022 | — | open, classified | Label provided for substrate vail contained incorrect expiration date. |
| Aug 15, 2018 | Z-2359-2019 | — | terminated | When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a defect occurs when a new sample(s) is inserted. This defect creates a mismatch between the sample name and the column header whereby the sample header will be offset by one sample. The recalling firm requests that you discontinue using this workflow to generate reports because the Quant batch table will not display fully analyzed results or save any changes made. |
| Jun 17, 2015 | Z-1737-2017 | — | terminated | The product was marketed without 510(k) clearance. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Agilent Technologies Waldbronn Baden-Wurttemberg · DE FEI 3009202467