10 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tecomet Global Unite Short Stem Instrumentation
FDA 510(k)
FDA Class 2
·Orthopedic
SIMPLY ICONIC SBM IMP 4.2X3.0 PLAT 13MML
FDA Adverse Event
Injury
·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·February 6, 2025
SPINEFRONTIER LUMBAR IBF SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AQUILION RXL
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
ACRYSOF TORIC
FDA Adverse Event
Other
·ALCON RESEARCH LTD / HUNTINGTON·Product code MJP·October 3, 2008
BREEZE CEMENT
FDA Adverse Event
Injury
·PENTRON CLINICAL·Product code EMA·August 15, 2011
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code KRG·July 8, 2013
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024