11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGICAL PREP RAZOR
FDA 510(k)MAC 1600 ECG ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Pure Vu System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·October 11, 2019
Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·December 28, 2016
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 30, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·October 10, 2012
TRUE DILATATION BALLOON
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code OZT·April 15, 2015
MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System
FDA Recall
Terminated
·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code LNH·December 21, 2018
MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code LNH·December 1, 2016