7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
POWDER FREE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ULTRA PCI
FDA 510(k)
FDA Class 2
·Radiology
PSK FEMORAL AND TIBIAL INSERT COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 20, 2015
INVASIVE CIRCUIT ASSEMBLY
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·January 15, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 10, 2014
Allura Xper FD10; Model Number: 722003;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026