8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
BARNES-HIND WETTING & SOAKING SOLUTION
FDA 510(k)
FDA Class 1
·Ophthalmic
KANGA PANTS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CAPMIX
FDA 510(k)
FDA Class 1
·Dental
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 3, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 15, 2012
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·August 10, 2010
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 30, 2025