23 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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36M - Navajo Tribal Utility Authority
FDA UDI
Certified Safety Manufacturing, Inc.·00766588012797·36M - Navajo Tribal Utility Authority
ASSISTO Universal Applicator Clamping Device
FDA 510(k)
FDA Class 2
·Radiology
Navajo Tribal Utility Authority - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588012780·Navajo Tribal Utility Authority - 18 Metal
GT990402 DIGITAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·July 2, 2020
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 31, 2023
2520274-2013-07849
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code MJO·December 18, 2013
HAHN TAPERED IMPLANT Ø5.0 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 17, 2024
HAHN TAPERED IMPLANT Ø5.0 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·May 29, 2024
HAHN TAPERED IMPLANT Ø5.0 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 16, 2024
HAHN TAPERED IMPLANT Ø5.0 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 15, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·March 6, 2012
INVANCE MALE SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTM·January 23, 2014
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·August 3, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 27, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 2, 2013
INVANCE MALE SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 23, 2014
UNKNOWN STRATTICE
FDA Adverse Event
Injury
·LIFECELL·Product code FTM·January 14, 2020