7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
VERONAL BUFFER
FDA 510(k)
FDA Class 2
·Hematology
PressureWire X Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 26, 2012
G2 FILTER SYSTEM - FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 31, 2013
CORAIL BROACH HANDLE
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·July 15, 2010
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025