11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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The Graft Bone Substitute
FDA 510(k)
FDA Class 2
·Dental
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031
FDA 510(k)
FDA Class 2
·Cardiovascular
DISPOSABLE ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
FUJIFILM DUODENOSCOPE MODEL ED-580T
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDT·September 5, 2023
FUJIFILM ENDOSCOPE
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDS·March 18, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
FUJIFILM DUODENOSCOPE ED-580T
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDT·March 5, 2025
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·October 22, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·August 4, 2011
PARADYM
FDA Adverse Event
Injury
·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code MRM·October 30, 2015
Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016