9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MASADA Modular Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL™ Sensi-Disc™ Streptomycin 300 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902316947·BD BBL™ Sensi-Disc™ Streptomycin 300 µg
MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000
FDA 510(k)
FDA Class 2
·Neurology
NMI PORT II CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 14, 2014
ATLAS II PLUS DR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 1, 2011
PELVICOL 2 X 4 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