83 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No
FDA Recall
Open, Classified
·Edan Diagnostics·Product code DQA·October 24, 2025
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
FDA Recall
Open, Classified
·Augustine Temperature Management, LLC·Product code DWJ·February 15, 2024
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
FDA Recall
Open, Classified
·Augustine Temperature Management, LLC·Product code DWJ·February 15, 2024
Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code BXN·May 17, 2024
Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code BXN·May 17, 2024
Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code BXN·May 17, 2024
Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code BXN·May 17, 2024
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
FDA Recall
Open, Classified
·IN MY BATHROOM LLC·Product code RHP·January 27, 2022
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
FDA Recall
Open, Classified
·B. Braun Medical, Inc.·Product code FPA·August 8, 2024
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
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FJK·August 15, 2024
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095DA
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FJK·August 15, 2024
STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FJK·August 15, 2024
STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FJK·August 15, 2024
STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095W
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FJK·August 15, 2024
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095D
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FJK·August 15, 2024
STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095L
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FJK·August 15, 2024
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·April 4, 2025
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
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