7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2
FDA 510(k)
FDA Class 2
·Anesthesiology
BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Implantcast ic-Bipolar Head System
FDA 510(k)
FDA Class 2
·Orthopedic
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·March 6, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·January 28, 2011
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·August 8, 2014
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026