45 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Surgical Face Mask (HNFM0304)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROGRAMALITH #'S 221, 222, 221A & 222A
FDA 510(k)
FDA Class 3
·Cardiovascular
TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
LAD, MODEL LAD-01
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUICKVUE AT-HOME OTC COVID-19 TEST
FDA Adverse Event
Malfunction
·QUIDELORTHO CORPORATION·Product code QKP·August 21, 2024
QUICKVUE AT-HOME OTC COVID-19 TEST
FDA Adverse Event
Malfunction
·QUIDELORTHO CORPORATION·Product code QKP·August 20, 2024
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 14, 2022
BINAXNOW COVID-19 ANTIGEN SELF TEST
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 15, 2021
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 13, 2022
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 13, 2022
AIRLIFE 2025 EDITION BROSELOW TAPE 36-2446 REV. 3
FDA Adverse Event
Other
·SUNMED GROUP HOLDINGS, LLC DBA AIRLIFE·Product code OKI·November 18, 2025
BINAXNOW COVID-19 SELF-TEST
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QKP·July 15, 2022
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 13, 2022
BINAXNOW COVID-19 SELF -TEST
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 6, 2021
BINAXNOW COVID-19 ANTIGEN SELF TEST
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 13, 2022
8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·November 4, 2008
APEX¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·August 24, 2011
SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GDW·July 11, 2013
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 15, 2021
CVS HEALTH AT HOME, COVID-19 TEST KIT
FDA Adverse Event
Malfunction
·QUIDELORTHO CORPORATION·Product code QKP·August 7, 2024