9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Vscan Air
FDA 510(k)
FDA Class 2
·Radiology
Esprit Ultra Fine Toothbrush
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063756267·Esprit Ultra Fine Toothbrush, compact, soft, 4 ...
LERADO AVANTICARE POWER WHEELCHAIR, MODEL PW-1800
FDA 510(k)
FDA Class 2
·Physical Medicine
Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 8, 2025
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 14, 2014
URETEX SUPPORT PP TRANSOBTUR2 KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·September 9, 2011
UNK
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·July 26, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013