15 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEGATIVE CONTROL SERUM FOR CF RO ID
FDA 510(k)
FDA Class 2
·Microbiology
BRILLIANT COMPONEER
FDA 510(k)
FDA Class 2
·Dental
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
FDA 510(k)
FDA Class 2
·Cardiovascular
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 5, 2014
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·October 15, 2012
HAKIM VALVE
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·May 22, 2015
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 23, 2014
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·June 3, 2021