14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
3M™ Forsus™
FDA UDI
3M UNITEK CORPORATION·00652221110367·Forsus(TM) Fatigue Resistant Device Push Rod Sh...
SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 12, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 12, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 12, 2024
ARCHITECT I2000SR ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·July 17, 2017
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 19, 2014
KNIFE
FDA Adverse Event
Malfunction
·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·October 20, 2010
LENSX LASER SYSTEM
FDA Adverse Event
Injury
·ALCON - LENSX LASERS, INC.·Product code OOE·December 19, 2012
ARCHITECT I2000SR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·June 17, 2021
ARCHITECT I2000SR ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·January 6, 2020
SmartPath to dStream for 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023