15 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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da Vinci Xi Surgical System; da Vinci X Surgical System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 5, 2025
UV PHOTOTHERAPY
FDA Adverse Event
Injury
·UNK·Product code FTC·January 27, 2021
UV PHOTOTHERAPY
FDA Adverse Event
Injury
·XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO.·Product code FTC·November 30, 2022
UV PHOTOTHERAPY
FDA Adverse Event
Injury
·UNK·Product code FTC·January 25, 2021
UV PHOTOTHERAPY LAMP
FDA Adverse Event
Injury
·ANGEL KISS LLC.·Product code FTC·February 3, 2021
UV PHOTOTHERAPY
FDA Adverse Event
Injury
·UNK·Product code FTC·January 26, 2021
UV PHOTOTHERAPY LAMP
FDA Adverse Event
Injury
·UNK·Product code FTC·January 29, 2021
UV PHOTOTHERAPY
FDA Adverse Event
Injury
·ANGEL KISS LLC·Product code FTC·February 2, 2021
UV PHOTOTHERAPY LAMP
FDA Adverse Event
Injury
·ANGEL KISS LLC.·Product code FTC·February 4, 2021
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZF·October 13, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 31, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·September 19, 2008