9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INOMAX DS (DELIVERY SYSTEM), MODEL 10003
FDA 510(k)
FDA Class 2
·Anesthesiology
E1200 AS1 Delivery System
FDA UDI
Engle Dental Systems, LLC·00850043433293·Utility Center Mounted AS1 Cuspidor Delivery Sy...
KILEJIAN CIRCUMCISOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·April 22, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 15, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012