26 results
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13ms
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Sources: EU EUDAMED, US FDA
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
Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
FDA Recall
Open, Classified
·Boston Scientific·Product code EZB·March 9, 2020
Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)
FDA Recall
Open, Classified
·Boston Scientific·Product code EZB·March 9, 2020
Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
FDA Recall
Open, Classified
·Boston Scientific·Product code EZB·March 9, 2020
Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110
FDA Recall
Open, Classified
·Boston Scientific·Product code EZB·March 9, 2020
Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators
FDA Recall
Open, Classified
·3B Medical, Inc.
203 Avenue A Nw Ste 300
Winter Haven FL 33881-4540·Product code BZB·November 27, 2024
Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080
FDA Recall
Open, Classified
·Boston Scientific·Product code EZB·March 9, 2020
Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
FDA Recall
Open, Classified
·Boston Scientific·Product code EZB·March 9, 2020
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
FDA Recall
Open, Classified
·Boston Scientific·Product code EZB·March 9, 2020
Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
FDA Recall
Open, Classified
·Boston Scientific·Product code EZB·March 9, 2020
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit
FDA Recall
Open, Classified
·Boston Scientific·Product code EZB·March 9, 2020
Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
FDA Recall
Open, Classified
·Boston Scientific·Product code EZB·March 9, 2020
Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
FDA Recall
Open, Classified
·Boston Scientific·Product code EZB·March 9, 2020
Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
FDA Recall
Open, Classified
·Boston Scientific·Product code EZB·March 9, 2020
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
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