14 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH
FDA 510(k)
FDA Class 2
·Dental
OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIMENSION PENTA H, DIMENSION PENTA H QUICK
FDA 510(k)
FDA Class 2
·Dental
PLATE BD CHROMAGAR O-157 20 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSI·August 10, 2021
PLATE BD CHROMAGAR O-157 20 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSI·August 10, 2021
CSF-FLOW CONTROL AVALVE, CONTOURED SMALL, HIGH PRESSURE
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·April 17, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 19, 2011
THERMACHOICE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code MKN·July 2, 2008
2CM PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 4, 2019
2CM PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·October 7, 2019
2CM PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·August 19, 2019
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022