10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LVivo Seamless
FDA 510(k)
FDA Class 2
·Radiology
Oticon
FDA UDI
Oticon A/S·05707131376107·OPN S 1, BTE PP 13 2.4G 105 C093
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113493·LAMELLAR BLADE #66-60 (BX/5)
4MP COLOR LCD MONITOR, RADIFORCERX430
FDA 510(k)
FDA Class 2
·Radiology
BIS/EEG MODULE
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 23, 2024
FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 9, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023