11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Electrodes with silver conductive
FDA 510(k)
FDA Class 2
·Neurology
WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
FDA 510(k)
FDA Class 2
·Anesthesiology
ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371
FDA 510(k)
FDA Class 2
·Cardiovascular
ISA CO2
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 30, 2022
BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·March 27, 2025
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 16, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 14, 2014
INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·August 18, 2025
EVEREST ® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·STRYKER-SPINE·Product code LXH·September 9, 2019
Ingenia 3.0T-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: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021