8 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tigereye CTO-Crossing Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05707131376121·OPN S 1, BTE PP 13 2.4G 105 C094
MODIFICATION TO N/T PROTEIN CONTROL SL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·October 21, 2008
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·CORDIS NEUROVASCULAR, INC.·Product code NJE·August 16, 2011
FLEXTEND
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 9, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023