21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)
FDA 510(k)
FDA Class 2
·Physical Medicine
Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
FDA 510(k)
FDA Class 2
·Anesthesiology
BD POSIFLUSH XS/SF
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·May 22, 2025
BD POSIFLUSH XS/SF
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·May 22, 2025
POSIFLUSH XS/SF
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·February 12, 2026
POSIFLUSH XS/SF
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·December 28, 2025
POSIFLUSH XS/SF
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·December 28, 2025
BD POSIFLUSH XS/SF
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·July 7, 2025
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 11, 2014
GYNECARE X-TRACT MOTOR DRIVE UNIT
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code HET·July 23, 2013
POSIFLUSH XS/SF
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·February 9, 2026
BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·February 13, 2018
BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·April 16, 2018
BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·February 13, 2018
BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·February 13, 2018
BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·February 13, 2018
BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·April 12, 2018
Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·October 21, 2020