25 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Y-Knot OneStep Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
ARTISTE SOLUTION WITH SYS_VB50 UPDATE
FDA 510(k)
FDA Class 2
·Radiology
NNC GOLD ABUTMENT FOR BRIDGES
FDA 510(k)
FDA Class 2
·Dental
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 17, 2023
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·June 16, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·June 16, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·October 22, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·February 12, 2025
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 22, 2014
ESSURE
FDA Adverse Event
Injury
·Product code HHS·June 21, 2013
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·July 14, 2011
CARDIOCHEK PLUS ANALYZERQ
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·August 18, 2022
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·July 28, 2023
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·May 24, 2024
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·January 6, 2023
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·January 11, 2024
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·November 21, 2023
SYNGO SUITE FOR ONCOLOGY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·June 14, 2024
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·February 24, 2023