8 results
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29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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T2 Plus
FDA 510(k)
FDA Class 2
·Radiology
M1 CAPNOGRAPHY MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
ACE PROXIMAL HUMERAL NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IMPLANT, ENDOSSEOUS, ROOT-FORM
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 28, 2025
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 3, 2011
SENSOR BSA
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·November 6, 2014
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 18, 2013
Access Thyroglobulin Calibrators
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·October 18, 2023