14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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cobas® liat CT/NG/MG nucleic acid test
FDA 510(k)
FDA Class 2
·Microbiology
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780383635·Integra® Jarit® Bone Hook, Large, 1" Hook
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690125488·Modular Knee Stem Pilot 19mm x 75mm
EAGLE ANTERIOR CERVIAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 28, 2025
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
3004475983-2008-00001
FDA Adverse Event
Other
·Product code GDG·February 11, 2008
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 24, 2008
TENDRIL ST
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 22, 2013
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025