9 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3.0T 16ch Breast Coil
FDA 510(k)
FDA Class 2
·Radiology
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
FDA 510(k)
FDA Class 2
·Hematology
CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 7, 2025
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 15, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 23, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 17, 2013
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·August 7, 2018
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·August 7, 2018