Agilent Technologies, Inc.
Medical device manufacturer in Carpinteria, CA.
45510(k) clearances
6PMA approvals
5recalls
Device types
- MWI Monitor, Physiological, Patient (Without… 11
- DSI Detector And Alarm, Arrhythmia 9
- MHX Monitor, Physiological, Patient(With… 5
- MKJ Automated External Defibrillators… 4
- IYN System, Imaging, Pulsed Doppler, Ultrasonic 3
- MLO Electrocardiograph, Ambulatory, With… 3
- DPS Electrocardiograph 2
- DSH Recorder, Magnetic Tape, Medical 2
- BSZ Gas-Machine, Anesthesia 1
- DQK Computer, Diagnostic, Programmable 1
- MHD Pump, Infusion, Gallstone Dissolution 1
- DQA Oximeter 1
- CBQ Analyzer, Gas, Enflurane, Gaseous-Phase… 1
- PFX System, Microarray-Based, Genome-Wide… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K163367 | GenetiSure Dx Postnatal AssayPFX · Traditional | 08/11/2017SE |
| K010949 | 2010 Plus Holter for WindowsMLO · Traditional | 09/28/2001SE |
| K012094 | Modification to Device Link System, Model M2376AMWI · Special | 07/20/2001SE |
| K011824 | Agilent M2636B Telemon B Monitor (Telemon B)DSI · Special | 07/02/2001SE |
| K010634 | Heartstream XL Defibibrillator/Monitor, Model M4735A, Heartstream XLT…MKJ · Traditional | 06/11/2001SE |
| K011578 | M2376A Devicelink System, Model M2376AMWI · Special | 06/08/2001SE |
| K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870AMKJ · Traditional | 05/02/2001SE |
| K011093 | Agilent Information Center Software for M3150,M3151,M3153 and M3154MHX · Special | 05/01/2001SE |
| K010453 | M2376A Devicelink SystemMWI · Special | 03/02/2001SE |
| K010342 | M2376A Devicelink System, Model M2376AMWI · Special | 02/14/2001SE |
| K003940 | 2010 Plus Holter for WindowsMLO · Special | 02/08/2001SE |
| K010048 | M2376A Devicelink SystemMWI · Traditional | 02/01/2001SE |
| K003763 | 2010 Plus Holter for WindowsMLO · Special | 01/05/2001SE |
| K003621 | St/Ar ST and Arrhythmia Software, Model Release D.0MHX · Special | 12/20/2000SE |
| K003565 | Heartstream FR2 AED, Model M3860A,M3861AMKJ · Special | 12/20/2000SE |
| K003622 | M2376A Devicelink System, Model M2376AMWI · Special | 12/18/2000SE |
| K002459 | Pagewriter 10/10I, Model M2662A Handheld ElectrocardiographDPS · Traditional | 11/08/2000SE |
| K003107 | M2376A Devicelink SystemMWI · Special | 10/19/2000SE |
| K002967 | M2376A Devicelink System, Model M2376AMWI · Special | 10/18/2000SE |
| K002470 | M2424A Sonos 5500/4500 Diagnostic Ultrasound System, Version B.2. 21330A TransducerIYN · Traditional | 09/08/2000SE |
| K001725 | Heartstream XL Defibrillator/Monitor, Model M4735AMKJ · Traditional | 09/08/2000SE |
| K002397 | M2430 Diagnostic Ultrasound System with the 21420 TransducerIYN · Traditional | 08/17/2000SE |
| K002009 | HP M2376A Device Link System, Model M2376AMWI · Special | 08/02/2000SE |
| K001776 | Modification to HP M2376A Device Link System, Model M2376AMWI · Special | 06/30/2000SE |
| K001664 | Compact Portable Patient Monitor with Wireless Alan, Model Alilent M3000A/M3046A Option…MHX · Special | 06/30/2000SE |
| K001711 | M2410B Imagepoint HX Multispecialty System, Version B.1IYN · Traditional | 06/20/2000SE |
| K001436 | Agilent M2636A Telemon MonitorDSI · Special | 06/07/2000SE |
| K994188 | Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5CBQ · Special | 05/19/2000SE |
| K001348 | St/Ar ST and Arrhythmia SoftwareMHX · Special | 05/17/2000SE |
| K001308 | Modification to Zymed Telemetry System, Model EasiviewDQA · Special | 05/17/2000SE |
| K001057 | Agilent Information Center Software for M3150A and M3153A and Agilent M2/M3/M4 Compact…DSI · Special | 05/03/2000SE |
| K000854 | Viridia Information Center Software for M3150A and M3153A, Viridia Telemetry System…MHX · Special | 04/10/2000SE |
| K000822 | Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and…DSI · Special | 04/06/2000SE |
| K000635 | Modification to HP M2376A Device Link SystemMWI · Special | 03/20/2000SE |
| K993907 | Viridia Information Center Software for M3154A Opt C22MHD · Special | 12/06/1999SE |
| K990093 | Zymed Telemetry System: Model EasiviewDSI · Traditional | 05/11/1999SE |
| K980186 | Zymed Telemetry SystemDSI · Traditional | 10/07/1998SE |
| K942781 | Digital Holter RecorderDSH · Traditional | 01/24/1995SE |
| K930806 | Zymed Holter Scanner Model 2010DQK · Traditional | 04/25/1994SE |
| K924672 | Zymed Telemetry Monitor Model T8010 (Preliminary)DSI · Traditional | 12/15/1992SE |
| K895208 | Zymed Model 1610DSI · Traditional | 12/12/1989SE |
| K854213 | Ari Standard Anesthesia RecordBSZ · Traditional | 12/19/1985SE |
| K841083 | Quikpage Arrhythmia Report GeneratorDSI · Traditional | 02/07/1985SE |
| K822970 | Holter RecorderDSH · Traditional | 11/03/1982SE |
| K822582 | Quikpage ScannerDPS · Traditional | 09/21/1982SE |
PMA approvals
- P250004 MMR IHC Panel pharmDx (Dako Omnis) · 08/15/2025 · 1 supplement
- P230016 MAGE-A4 IHC 1F9 pharmDx · 08/01/2024 · 3 supplements
- P210026 Ki-67 IHC pharmDx · 10/12/2021 · 3 supplements
- P150025 PD-L1 IHC 28-8 pharmDx · 10/09/2015 · 17 supplements
- P150013 PD-L1 Ihc 22C3 Pharmdx · 10/02/2015 · 34 supplements
- P030044 Dakocytomation Egfr Pharmdx · 02/12/2004 · 7 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1544-2025 Class II | GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female…DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component… | 03/20/2025Open, Classified |
| Z-1919-2024 Class II | Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer…There is the potential for the front plexiglass door of the automated slide processing system to break… | 04/02/2024Open, Classified |
| Z-1384-2022 Class III | Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2…Label provided for substrate vail contained incorrect expiration date. | 05/20/2022Open, Classified |
| Z-2359-2019 Class II | MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole…When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view… | 08/15/2018Terminated |
| Z-1737-2017 Class II | Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto…The product was marketed without 510(k) clearance. | 06/17/2015Terminated |