7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Inspire ICE aka Inspire ICE Clear Brackets
FDA 510(k)
FDA Class 2
·Dental
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
RESCAN 700, CALLISTO EYE
FDA 510(k)
FDA Class 2
·Ophthalmic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
6000 CMS IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 23, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
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