10 results
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18ms
·
Sources: EU EUDAMED, US FDA
HUNTER AIR CLEANERS MODEL NOS. 30100/30250/30300
FDA 510(k)
FDA Class 2
·General Hospital
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515238251·Pennington Elev, 8 1/4"
Guided Inserter
FDA UDI
BICON, LLC·00813110026194·3.0mm Guided Inserter - 2.0mm Post
SOLEA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·November 24, 2010
IAB: 8 FR - 30 CC FOS
FDA Adverse Event
Injury
·ARROW INTERNATIONAL INC·Product code DSP·January 23, 2013
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NIQ·July 11, 2014
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
FDA Enforcement
Class II
·Ongoing·Barco N.V.·July 2, 2025
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
FDA Recall
Open, Classified
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code DXJ·May 9, 2025