19 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REGIONAL OXIMETER SYSTEM, MODEL 7600
FDA 510(k)
FDA Class 2
·Cardiovascular
LEONE SPA
FDA UDI
LEONE SPA·08033707065708·INTRAORAL ELASTICS 4,5 oz 1/4" red
Medline
FDA UDI
MEDLINE INDUSTRIES, INC.·10884389028025·FENESTRATED DRAPE, 24 X 40 W/TAPE
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450213650·
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·July 24, 2014
FULL FACE MASK
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code MNT·September 9, 2011
MUSCLE STIMULATOR SA-100
FDA 510(k)
FDA Class 2
·Physical Medicine
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 18, 2024
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. HOMECARE PRODUCT, INC·Product code INI·May 2, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 15, 2014
ENTERALITE INFINITY ENTERAL FEEDING SET
FDA Adverse Event
Other
·MOOG MEDICAL DEVICES GROUP·Product code KNT·May 2, 2011
FULL FACE MASK
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code MNT·September 13, 2011
FULL FACE MASK
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code MNT·September 13, 2011
VARIPULSE¿ BI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code QZI·September 3, 2025
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·November 30, 2021
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·July 7, 2023
ARCHITECT C4000
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·November 4, 2024
ALINITY I FREE T4 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CEC·October 28, 2024