23 results
·
14ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code LKM·December 19, 2023
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
FDA Recall
Open, Classified
·Micro-X Ltd.
Unit 14 6 Mab Eastern Promenade
Tonsley Australia·Product code IZL·March 27, 2026
iQ Waste Well Adapter, Part Number: 700-3393
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code LKM·December 19, 2023
REV 2 Flowcell Capsule Spare, Part Number: C04154
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code LKM·December 19, 2023
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
FDA Recall
Open, Classified
·Micro-X Ltd.
Unit 14 6 Mab Eastern Promenade
Tonsley Australia·Product code IZL·November 28, 2023
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code KQO·April 5, 2023
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code KQO·April 5, 2023
iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code LKM·December 19, 2023
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code KQO·April 5, 2023
MICRO-X Rover Mobile X-ray System, # MXU-RV35
FDA Recall
Open, Classified
·Micro-X Ltd.
Unit 14 6 Mab Eastern Promenade
Tonsley Australia·Product code IZL·May 31, 2023
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
FDA Recall
Open, Classified
·Micro-X Ltd. A14 6 MAB Eastern Promenade Tonsley Australia·Product code IZL·August 31, 2022
MICRO-X Rover Mobile X-ray System, # MXU-RV35
FDA Recall
Open, Classified
·Micro-X Ltd.
Unit 14 6 Mab Eastern Promenade
Tonsley Australia·Product code IZL·October 22, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV19
FDA Recall
Open, Classified
·Micro-X Ltd.
Unit 14 6 Mab Eastern Promenade
Tonsley Australia·Product code IZL·October 23, 2024
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code KQO·April 5, 2023
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Recall
Open, Classified
·Micro-X Ltd.
Unit 14 6 Mab Eastern Promenade
Tonsley Australia·Product code IZL·April 4, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Recall
Open, Classified
·Micro-X Ltd.
Unit 14 6 Mab Eastern Promenade
Tonsley Australia·Product code IZL·March 28, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Recall
Open, Classified
·Micro-X Ltd.
Unit 14 6 Mab Eastern Promenade
Tonsley Australia·Product code IZL·March 28, 2025
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
FDA Recall
Open, Classified
·Wilson-Cook Medical Inc.·Product code QAU·May 22, 2023
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
FDA Recall
Open, Classified
·Wilson-Cook Medical Inc.·Product code QAU·May 22, 2023
HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code QLU·August 25, 2021