11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDOGATOR Hybrid Irrigation Tubing
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694021906·FPS 18mm Cannulated Metatarsal Reamer
Sunset Heated CPAP Tube
FDA 510(k)
FDA Class 2
·Anesthesiology
MONTAGE Settable, Resorbable Hemostatic Bone Putty
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 11, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
PSX INTERBODY SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·September 1, 2011
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022