9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANESTHESIA KIT, EPIDURAL BLOCK, CONTINU.
FDA 510(k)
FDA Class 2
·Anesthesiology
NOSE CLIP
FDA 510(k)
FDA Class 1
·Anesthesiology
VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4
FDA 510(k)
FDA Class 2
·General Hospital
PENUMBRA SYSTEM REPERFUSION CATHETER 054
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·October 3, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 12, 2007
CVC KIT: 3-LUMEN 5.5 FR X 30 CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQO·February 18, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025