Agilent Technologies, Inc.
Agilent Technologies, Inc. holds FDA 510(k) medical device clearances, first cleared 1985, most recent 2017, with 4 FDA device recalls on record.
Top product codes for Agilent Technologies, Inc.
FDA recalls by Agilent Technologies, Inc.
- Z-1544-2025 — 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).
- Z-1384-2022 — 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
- Z-2359-2019 — 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 intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass.
- Z-1737-2017 — 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 500/pk; A400150SK - Bond Elut DMS Card Starter Kit A42001 - Bond Elut MDS Card Accessory Pack Product Usage: For use in the analysis of dried blood spots and other biological matrices in research applications for drug metabolism pharmacokinetics/ absorption, distribution. metabolism and excretion (DMPK/ ADME) studies.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Agilent Technologies, Inc.
- K163367 — GenetiSure Dx Postnatal Assay
- K012094 — MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A
- K011824 — AGILENT M2636B TELEMON B MONITOR (TELEMON B)
- K010634 — HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B
- K011578 — M2376A DEVICELINK SYSTEM, MODEL M2376A
- K003819 — HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
- K011093 — AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
- K010453 — M2376A DEVICELINK SYSTEM
- K010342 — M2376A DEVICELINK SYSTEM, MODEL M2376A
- K010048 — M2376A DEVICELINK SYSTEM
- K003565 — HEARTSTREAM FR2 AED, MODEL M3860A,M3861A
- K003621 — ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0
- K003622 — M2376A DEVICELINK SYSTEM, MODEL M2376A
- K002459 — PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH
- K003107 — M2376A DEVICELINK SYSTEM
- K002967 — M2376A DEVICELINK SYSTEM, MODEL M2376A
- K001725 — HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
- K002470 — M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER
- K002397 — M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER
- K002009 — HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
- K001664 — COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120
- K001776 — MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
- K001711 — M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1
- K001436 — AGILENT M2636A TELEMON MONITOR
- K001348 — ST/AR ST AND ARRHYTHMIA SOFTWARE
- K001057 — AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR
- K000854 — VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER
- K000635 — MODIFICATION TO HP M2376A DEVICE LINK SYSTEM
- K993907 — VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22
- K854213 — ARI STANDARD ANESTHESIA RECORD
Data sourced from openFDA. This site is unofficial and independent of the FDA.