5 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
FDA Enforcement
Class II
·Ongoing·BioFire Diagnostics, LLC·April 16, 2025
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
FDA Enforcement
Class II
·Ongoing·Draeger Medical, Inc.·October 20, 2021
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
FDA Enforcement
Class II
·Ongoing·Human Care Hc Sweden Ab·April 17, 2024
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS
FDA Enforcement
Class II
·Ongoing·Philips North America LLC·April 13, 2022
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
FDA Enforcement
Class II
·Ongoing·Medtronic Navigation, Inc.-Littleton·August 30, 2023