9 results
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13ms
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Sources: EU EUDAMED, US FDA
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 Recall
Open, Classified
·Draeger Medical, Inc.·Product code CBK·September 10, 2021
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
FDA Recall
Open, Classified
·BioFire Diagnostics, LLC·Product code QDS·February 27, 2025
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 Recall
Open, Classified
·Human Care Hc Sweden Ab Arstaangsvagen 21 B Stockholm Sweden·Product code FSA·February 23, 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 Recall
Open, Classified
·Philips North America LLC·Product code MKJ·February 4, 2022
PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.
FDA Recall
Open, Classified
·Envisiontec US Llc·Product code EBZ·January 20, 2022
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
FDA Recall
Open, Classified
·Atrium Medical Corporation·Product code GBZ·September 29, 2023
Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028
FDA Recall
Open, Classified
·Atrium Medical Corporation·Product code GBZ·April 21, 2022
Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.
FDA Recall
Open, Classified
·Handpiece Headquarters·Product code EBZ·April 4, 2018
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 Recall
Open, Classified
·Medtronic Navigation, Inc.-Littleton·Product code OWB·July 25, 2023