28 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Kubtec Mozart Supra
FDA 510(k)
FDA Class 2
·Radiology
MALTA
FDA 510(k)
FDA Class 2
·Dental
Catalys Precision Laser System
FDA 510(k)
FDA Class 2
·Ophthalmic
DEEP BRAIN STIMULATOR LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·February 6, 2008
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·February 8, 2008
OPTI-FREE REPLENISH MULTI-PURPOSE DISINFECTING SOLUTION
FDA Adverse Event
Other
·ALCON - FT WORTH, ALCON LABORATORIES, INC·Product code LPN·November 16, 2007
OPHTHALMIC FEMTOSECOND LASER
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·February 9, 2021
AUTOPULSE® LIFEBAND
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code DRM·October 24, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 27, 2011
SM104 MSERIES W5TH WHLOBS3/07
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 1, 2013
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021
PATIENT INTERFACE NIM4CPB1 NIM 4.0
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·October 28, 2025
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·February 16, 2021
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·February 8, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 19, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 19, 2021