11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KOREBALANCE (KINESTHETIC ABILITY TRAINER)
FDA 510(k)
FDA Unclassified
·Unknown
LINEAR 3-4
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 20, 2024
SIMPLICITY WINGED QD INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
FDA 510(k)
FDA Class 2
·General Hospital
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 27, 2025
THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·April 22, 2013
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·A.I.D.D LONGFORD·Product code DHA·April 27, 2011
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code LDD·July 1, 2008
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