10 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC
FDA 510(k)
FDA Class 2
·Cardiovascular
DIXI 2
FDA 510(k)
FDA Class 2
·Dental
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 15, 2021
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2024
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 10, 2022
CONTOUR TS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 2, 2013
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
UNKNOWN·Product code IKX·September 15, 2014
ATTAIN STARFIX
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 16, 2011
Alcon Custom Ophthalmic Surgical Procedure Packs
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·April 7, 2021