15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
FDA 510(k)
FDA Class 2
·Radiology
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
AGILE ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024
BD ULTRA FINE PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 27, 2020
AGILE ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024
AGILE ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 20, 2025
AGILE ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025
AGILE ESOPHAGEAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 30, 2025
PEN NDL 32GA 4MM 14BAG 700CASE JP
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·August 7, 2019
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 6, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 5, 2011
OT VERIO IQ METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013
BD VACUTAINER® SST¿ II ADVANCE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 28, 2018
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025