8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
JELCO & KVO CATHETER PLACEMENT UNIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Lyra
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SYSTEM II
FDA 510(k)
FDA Class 1
·Cardiovascular
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 5, 2014
INSYNC III MARQUIS
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·October 15, 2012
UROVIEW
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 6, 2010
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025