14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vivaer ARC Stylus
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRACKPORT
FDA 510(k)
FDA Class 2
·Radiology
D2RF DIGITAL DYNAMIC REMOTE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 3, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 18, 2024
VANGUARD ROCC POR FEM S60 L
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·February 3, 2026
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 17, 2013
UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·September 25, 2008
VANGUARD MONO FINNED STM TIB 71X8
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·August 9, 2023
PANTHER FUSION ADV/HMPV/RV ASSAY
FDA Adverse Event
Injury
·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021
VANGUARD ROCC POR FEM S60 L
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code JWH·February 20, 2025
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026