9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDI-MIST PORTA. COMPRESSOR DRIVEN
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LEADLINER CS LEAD DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 27, 2014
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 15, 2012
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·September 8, 2010
MENISCAL APPLIER, OMNISPAN
FDA Adverse Event
Injury
·DEPUY MITEK·Product code GEF·August 3, 2017
Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 78127 (OUS)
FDA Enforcement
Class II
·Terminated·Philips North America Llc·September 1, 2021
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021