12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
BD BBL™ Sensi-Disc™ Cefaclor 30 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902316535·BD BBL™ Sensi-Disc™ Cefaclor 30 µg
DATEX-OHMEDA HMEF 750
FDA 510(k)
FDA Class 2
·Anesthesiology
LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
COROX OTW 75-UP STEROID
FDA Adverse Event
Injury
·BIOTRONIK GMBH & CO.·Product code MRM·November 14, 2008
UROMAX ULTRA¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code EZN·September 1, 2011
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·July 12, 2013
KIDS OXYGENATOR D101
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 4, 2025
BD BBL Sensi Disc Cefaclor - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022