9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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autoSCORE (V 2.0.0)
FDA 510(k)
FDA Class 2
·Neurology
Cascadia™ Interbody System
FDA UDI
VB Spine LLC·10888857369825·Trial, Size 12x14x7 mm, 20°
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EXA
FDA 510(k)
FDA Class 2
·Radiology
20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 15, 2017
SUPERA BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·IDEV TECHNOLOGIES, INC·Product code FGE·November 25, 2008
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 29, 2011
SYNCHRON® LX® I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025