Company ยท US
Agilent Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2017. Name variants (Inc, Corp, punctuation) are merged.
45510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 11 |
| DSI | Detector And Alarm, Arrhythmia | 9 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 5 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 4 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 3 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 3 |
| DPS | Electrocardiograph | 2 |
| DSH | Recorder, Magnetic Tape, Medical | 2 |
| PFX | System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection | 2 |
| BSZ | Gas-Machine, Anesthesia | 1 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 1 |
| DOP | Mass Spectrometer, Clinical Use | 1 |
| DQA | Oximeter | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 |
| KPA | Slide Stainer, Automated | 1 |
| MHD | Pump, Infusion, Gallstone Dissolution | 1 |
| PJC | Newborn Screening Specimen Collection Paper | 1 |
| PPM | General Purpose Reagent | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 11, 2017 | K163367 | GenetiSure Dx Postnatal Assay Agilent Technologies, Inc. | PFX |
| Sep 28, 2001 | K010949 | 2010 PLUS HOLTER FOR WINDOWS Agilent Technologies | MLO |
| Jul 20, 2001 | K012094 | MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A Agilent Technologies, Inc. | MWI |
| Jul 2, 2001 | K011824 | AGILENT M2636B TELEMON B MONITOR (TELEMON B) Agilent Technologies, Inc. | DSI |
| Jun 11, 2001 | K010634 | HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B Agilent Technologies, Inc. | MKJ |
| Jun 8, 2001 | K011578 | M2376A DEVICELINK SYSTEM, MODEL M2376A Agilent Technologies, Inc. | MWI |
| May 2, 2001 | K003819 | HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A Agilent Technologies, Inc. | MKJ |
| May 1, 2001 | K011093 | AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 Agilent Technologies, Inc. | MHX |
| Mar 2, 2001 | K010453 | M2376A DEVICELINK SYSTEM Agilent Technologies, Inc. | MWI |
| Feb 14, 2001 | K010342 | M2376A DEVICELINK SYSTEM, MODEL M2376A Agilent Technologies, Inc. | MWI |
| Feb 8, 2001 | K003940 | 2010 PLUS HOLTER FOR WINDOWS Agilent Technologies | MLO |
| Feb 1, 2001 | K010048 | M2376A DEVICELINK SYSTEM Agilent Technologies, Inc. | MWI |
| Jan 5, 2001 | K003763 | 2010 PLUS HOLTER FOR WINDOWS Agilent Technologies | MLO |
| Dec 20, 2000 | K003621 | ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 Agilent Technologies, Inc. | MHX |
| Dec 20, 2000 | K003565 | HEARTSTREAM FR2 AED, MODEL M3860A,M3861A Agilent Technologies, Inc. | MKJ |
| Dec 18, 2000 | K003622 | M2376A DEVICELINK SYSTEM, MODEL M2376A Agilent Technologies, Inc. | MWI |
| Nov 8, 2000 | K002459 | PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH Agilent Technologies, Inc. | DPS |
| Oct 19, 2000 | K003107 | M2376A DEVICELINK SYSTEM Agilent Technologies, Inc. | MWI |
| Oct 18, 2000 | K002967 | M2376A DEVICELINK SYSTEM, MODEL M2376A Agilent Technologies, Inc. | MWI |
| Sep 8, 2000 | K002470 | M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER Agilent Technologies, Inc. | IYN |
| Sep 8, 2000 | K001725 | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A Agilent Technologies, Inc. | MKJ |
| Aug 17, 2000 | K002397 | M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER Agilent Technologies, Inc. | IYN |
| Aug 2, 2000 | K002009 | HP M2376A DEVICE LINK SYSTEM, MODEL M2376A Agilent Technologies, Inc. | MWI |
| Jun 30, 2000 | K001776 | MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A Agilent Technologies, Inc. | MWI |
| Jun 30, 2000 | K001664 | COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120 Agilent Technologies, Inc. | MHX |
| Jun 20, 2000 | K001711 | M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1 Agilent Technologies, Inc. | IYN |
| Jun 7, 2000 | K001436 | AGILENT M2636A TELEMON MONITOR Agilent Technologies, Inc. | DSI |
| May 19, 2000 | K994188 | MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 Agilent Technologies, GmbH, DE | CBQ |
| May 17, 2000 | K001348 | ST/AR ST AND ARRHYTHMIA SOFTWARE Agilent Technologies, Inc. | MHX |
| May 17, 2000 | K001308 | MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW Agilent Technologies | DQA |
| May 3, 2000 | K001057 | AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR Agilent Technologies, Inc. | DSI |
| Apr 10, 2000 | K000854 | VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER Agilent Technologies, Inc. | MHX |
| Apr 6, 2000 | K000822 | AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR Agilent Technologies, GmbH, DE | DSI |
| Mar 20, 2000 | K000635 | MODIFICATION TO HP M2376A DEVICE LINK SYSTEM Agilent Technologies, Inc. | MWI |
| Dec 6, 1999 | K993907 | VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22 Agilent Technologies, Inc. | MHD |
| May 11, 1999 | K990093 | ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW Agilent Technologies | DSI |
| Oct 7, 1998 | K980186 | ZYMED TELEMETRY SYSTEM Agilent Technologies | DSI |
| Jan 24, 1995 | K942781 | DIGITAL HOLTER RECORDER Agilent Technologies | DSH |
| Apr 25, 1994 | K930806 | ZYMED HOLTER SCANNER MODEL 2010 Agilent Technologies | DQK |
| Dec 15, 1992 | K924672 | ZYMED TELEMETRY MONITOR MODEL T8010 (PRELIMINARY) Agilent Technologies | DSI |
| Dec 12, 1989 | K895208 | ZYMED MODEL 1610 Agilent Technologies | DSI |
| Dec 19, 1985 | K854213 | ARI STANDARD ANESTHESIA RECORD Agilent Technologies, Inc. | BSZ |
| Feb 7, 1985 | K841083 | QUIKPAGE ARRHYTHMIA REPORT GENERATOR Agilent Technologies | DSI |
| Nov 3, 1982 | K822970 | HOLTER RECORDER Agilent Technologies | DSH |
| Sep 21, 1982 | K822582 | QUIKPAGE SCANNER Agilent Technologies | DPS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2025 | Agilent Technologies, Inc. GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A). Open, Classified |
PFX | K163367 |
| May 29, 2024 | Agilent Technologies Brand Name: Dako CoverStainer, Dako CoverStainer CPO
Product Name: CoverStainer, CoverStainer CPO
Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E
Software Version: N/A
Product Description: M Open, Classified |
KPA | None listed |
| May 20, 2022 | Agilent Technologies, Inc. Kit Label:
Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2
Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21
Vial Labels:
Mat. No K589911-21512 Open, Classified |
PPM | None listed |
| Aug 15, 2018 | Agilent Technologies, Inc. MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420
Product Usage:
A mass spectrometer for clinical use is a device int Terminated |
DOP | None listed |
| Jun 17, 2015 | Agilent Technologies, Inc. Bond Elut OMS (Dried Matrix Spotting)' Product;
Catalog model numbers:
5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk;
A400150 - Bond Elut EMS Card 50/Pk;
A400150K - Bond Elut DMS Card BULK 50 Terminated |
PJC | None listed |