9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XENOVIEW 3.0T Chest Coil
FDA 510(k)
FDA Class 2
·Radiology
BD BBL™ Sensi-Disc™ Norfloxacin 10 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902316474·BD BBL™ Sensi-Disc™ Norfloxacin 10 µg
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 11, 2024
TRINITY ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
FDA 510(k)
FDA Class 2
·General Hospital
EXELTRA 190 - SINGLE USE HIGHFLUX DIALYZER
FDA Adverse Event
Injury
·NIPRO CORP·Product code KDI·November 14, 2008
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·September 1, 2011
PELVICOL 4 X 12 CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·July 12, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022