9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
EdgeFlow UW20
FDA 510(k)
FDA Class 2
·Radiology
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252237200·ceraMotion® Me Chroma Concept Dentin 7, 20 g / ...
The Entasis Dual-Lead Sacroiliac Implant
FDA 510(k)
FDA Class 2
·Orthopedic
SC CERAMIC BALL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·March 4, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 14, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SAO PAULO·Product code KPE·September 16, 2011
VENTRIO ST
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·July 24, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025