77 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
FDA 510(k)
FDA Class 2
·Cardiovascular
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·December 10, 2024
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·January 5, 2023
CERAROOT IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026
NEXTAR INFRARED CAMERA
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·September 10, 2021
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·July 14, 2011
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014
MW5030685
FDA Adverse Event
Injury
·June 21, 2013
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 19, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 8, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 9, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 19, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 26, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 3, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·March 9, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 27, 2026