12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Soreal Press, Soreal CAD
FDA 510(k)
FDA Class 2
·Dental
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120694·Guidewire 2.5x230mm Partially Thrd
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120687·Guidewire 2.5x230mm Sgl Trocar
BD PARADIGM LINK BLOOD GLUCOSE MONITOR
FDA Adverse Event
Other
·BECTON DICKINSON·Product code NBW·November 10, 2005
AMATOMICAL SHOULDER WITH REMOVABLE HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
BEARING NSPVA EMBOLIZATION PARTICLES
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 27, 2023
CV EVOLUTIONS SAPHLITE
FDA Adverse Event
Other
·TELEFLEX MEDICAL·Product code KDQ·November 7, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
PWRD ECH FLEX 60MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 16, 2013
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·September 8, 2020
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026