8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
REDEMPTION Charcot Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IMPLANT, ENDOSSEOUS, ROOT-FORM
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 28, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
SCRDRIVERSHAFT T15 STD
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·July 18, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code OWB·November 18, 2015
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025