29 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IDSS SLC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HHM
FDA UDI
Oticon A/S·05707131262301·H100, RITE 312 WL SIL HHM
DreamWear Full
FDA UDI
Respironics, Inc.·00606959045989·DreamWear Full Mask, Wide, with Small Frame, wi...
Brasseler USA
FDA UDI
Provision·B504OMKM334130·
Brasseler USA
FDA UDI
Provision·00810041064981·
SPINEASSIST DEVICE
FDA 510(k)
FDA Class 2
·Neurology
ASCEND SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 22, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 5, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·January 6, 2020
TRUWAVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
ESTRADIOL II
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CHP·June 20, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP·Product code CBK·August 22, 2008
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·September 2, 2020
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 10, 2025
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·September 5, 2025
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·May 8, 2020
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·May 8, 2020