17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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syngo.CT Lung CAD (Version VD30)
FDA 510(k)
FDA Class 2
·Radiology
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022564·400 micron core/730 micron OD SMA Diode Laser F...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111147661·SKLIT STEVENS SCIS CVD BB 4.5"
RANFAC BONE MARROW ASPIRATION NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED
FDA 510(k)
FDA Class 1
·General Hospital
PEN NDL 32G 4MM HP 100 BOX 1200 US
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 14, 2021
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·September 14, 2016
PEN NDL 32G 4MM PRO
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·July 21, 2021
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND·Product code FMI·February 5, 2024
TSRH 3DX
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code LXH·March 10, 2026
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 12, 2008
ALLEGRETTO WAVE
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·August 26, 2011
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·July 17, 2013
PEN NDL 32G 4MM PRO
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·September 9, 2021
BD NANO¿ 2ND GEN PEN NEEDLES 4MM X 32G
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·August 12, 2022
INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·January 13, 2021
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015