12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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iRAD
FDA 510(k)
FDA Class 2
·Radiology
Oticon
FDA UDI
Oticon A/S·05707131376213·OPN S 1, MINIRITE T 312 2.4G C090
Deltec
FDA UDI
ICU MEDICAL, INC.·10610586025143·
2GC HIP/KNEE MODULAR SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO N PROTEIN STANDARD SL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2024
ALL THREAD PEEK ANCHOR
FDA Adverse Event
Malfunction
·BIOMET, INC.·Product code KGS·October 19, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
INGENIO
FDA Adverse Event
Injury
·GUIDANT PUERTO RICO BV·Product code NVZ·July 9, 2013
DEKA LIPOAI
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023