11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MULTIPLE NAME
FDA 510(k)
FDA Class 1
·General Hospital
CASCADIA™ Interbody System
FDA UDI
VB Spine LLC·10888857554733·Trial Size 16x20x14 mm, Convex
PSL ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FIBERFILL SGP
FDA 510(k)
FDA Class 1
·Dental
145-DEG PE 42MM HUM LINER +2.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 30, 2026
MONGOOSE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·TOGO MEDIKIT CO.LTD.·Product code DQO·December 15, 2017
WALLSTENT? BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·May 22, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·September 26, 2014
IPUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 14, 2011
BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 18, 2018
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026