9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
FDA 510(k)
FDA Class 2
·Cardiovascular
Medical surgical mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ERTAPENEM 10UG BBL SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
VOYAGER RX CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 30, 2008
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·August 23, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Death
·MPRI·Product code LWS·July 11, 2013
TRANSMITTER MMT-7841ZN GST5G US
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PQF·October 17, 2025
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 28, 2014
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025