8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MANIFOLD KIT
FDA 510(k)
FDA Class 1
·Anesthesiology
N/A
FDA UDI
Zimmer, Inc.·00889024133303·
FINDRWIRZ GUIDE WIRE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
HD LifeSciences Cervical IBFD System
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·October 5, 2012
COAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·September 12, 2007
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025