14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NobelPerfect Abutments
FDA 510(k)
FDA Class 2
·Dental
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193023445·B-P HIP SELF-ALIGNING ACETABULAR CUP & BEARING ...
SYNOVO HIP COMPONENTS
FDA UDI
Synovo Production·00814193026125·HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28...
DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PC ECG
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 22, 2011
BENEVIEW /MPM MODULE
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC·Product code MHX·May 21, 2013
STERRAD 100S STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·September 19, 2008
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·June 6, 2025
HEMOSIL ACUSTAR HIT-IGG (PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·April 8, 2025
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020