24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPTIBAND LC
FDA 510(k)
FDA Class 2
·Dental
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032407·Baltic Denture System BDLoad ↓ Lw6 PLSEum4DFl B...
ICU Medical
FDA UDI
ICU MEDICAL, INC.·00840619060008·TriOx™ SvO2 PA Catheter P7110-EH, 7.5F, 110cm, ...
ICU Medical
FDA UDI
ICU MEDICAL, INC.·00840619085957·Opticath Catheter P7110-EH, 7.5F, 110 cm, Hepar...
Octane Straight
FDA UDI
Choice Spine, LP·10885862237781·
Octane Straight PC
FDA UDI
Choice Spine, LP·10885862278210·
PACEART TX3 CARDIAC EVENT RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 6, 2025
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 1, 2013
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·March 28, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·April 17, 2008
ARCHITECT ANTI-TPO
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 11, 2025
ALINITY I ANTI-TPO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013
ALINITY I ANTI-TPO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025
ALINITY I ANTI-TPO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 16, 2025
ARCHITECT ANTI-TPO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JZO·May 23, 2025
ALINITY I ANTI-TPO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·March 17, 2025