10 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
NATRELLE SILICONE-FILLED BREAST IMPLANTS
FDA Adverse Event
Malfunction
·ALLERGAN, INC.·Product code FTR·August 13, 2020
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
FDA 510(k)
FDA Class 2
·Neurology
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 17, 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