9 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Caas Qardia
FDA 510(k)
FDA Class 2
·Radiology
S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
PMT TRUSCAN SURFACE ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 23, 2024
TRACH FLEX DIC CUF 7.0MM
FDA Adverse Event
Malfunction
·SMITHS HEALTHCARE MFG SA DE C.V.·Product code BTO·September 18, 2008
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 15, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 9, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023