1,820 results · 14ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

FDA Recall
Open, Classified ·GE Medical Systems, LLC·Product code MUE·October 24, 2025

GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications.

FDA Recall
Terminated ·GE Healthcare, LLC·Product code IZI·May 4, 2011

BD Bactec Blood Culture Procedural Tray, Cat. Number 442805 Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 Used in conjunction with the blood collection system.

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JGE·April 22, 2011

(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.

FDA Recall
Open, Classified ·GE Healthcare, LLC·Product code LLZ·July 15, 2022

GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system

FDA Recall
Terminated ·Product code RCE·January 13, 2015

GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.

FDA Recall
Terminated ·Product code RCE·January 13, 2015

EVair air compressor, model numbers: M1230849 and M1230847

FDA Recall
Open, Classified ·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023

EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002

FDA Recall
Open, Classified ·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023

EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849;

FDA Recall
Open, Classified ·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023

GE Precision 500D, model 2288798, 2289299, 2290479, 2305472, 2305473, 2305495, 2336900, 2345243, 2401181, 2403790, 2403791, 2404103, 2407276, 2407576, 5179385, 2289299-2, 2290479-2, 2345260-12, 2345260-3, 2403790-3, and 2403791-3, GE Medical Systems - Americas: Milwaukee, USA. The device is used to perform fluoroscopic examination of human anatomy.

FDA Recall
Terminated ·GE Healthcare·Product code JAA·January 2, 2008

NM 830 Model # H3910AC

FDA Recall
Terminated ·GE Healthcare, LLC·Product code KPS·August 14, 2020

NM/CT 870 DR Model # H3100AS

FDA Recall
Terminated ·GE Healthcare, LLC·Product code KPS·August 14, 2020

Discovery 670 DR Model # H3100BT

FDA Recall
Terminated ·GE Healthcare, LLC·Product code KPS·August 14, 2020

NM/CT 860, SPECT/CT

FDA Recall
Terminated ·GE Healthcare, LLC·Product code KPS·August 14, 2020

Discovery NM 630 Model # H3101RH

FDA Recall
Terminated ·GE Healthcare, LLC·Product code KPS·August 14, 2020

NM/CT 870 CZT Model # H3906CW

FDA Recall
Terminated ·GE Healthcare, LLC·Product code KPS·August 14, 2020

NM/CT 850 Model Number: H3907AD

FDA Recall
Terminated ·GE Healthcare, LLC·Product code KPS·August 14, 2020

Discovery NM670 Pro Model # H3100XB

FDA Recall
Terminated ·GE Healthcare, LLC·Product code KPS·August 14, 2020

GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Worksation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2,GE Healthcare, Waukesha, WI. 53188

FDA Recall
Terminated ·GE Healthcare·Product code LLZ·September 10, 2007

GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.

FDA Recall
Terminated ·Product code RCE·December 16, 2015