16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3M HI-STRENGTH MED. TAPE #1534
FDA 510(k)
FDA Class 1
·General Hospital
VITROS
FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750002368·VITROS Immunodiagnostic Products CA 19-9™ Range...
PULSE
FDA UDI
Nuvasive, Inc.·00887517996138·PULSE Adapter, VGA to DVI
ACUMED
FDA UDI
Acumed LLC·10806378094965·3.5mm Cannulated Tap
BD¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·June 29, 2018
BD¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·August 17, 2018
POLESTAR N-10
FDA 510(k)
FDA Class 2
·Radiology
ICON, MODEL C3
FDA 510(k)
FDA Class 2
·Cardiovascular
BD¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·May 21, 2018
PULSE GEN MODEL 102R
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·May 9, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·October 23, 2012
PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·August 17, 2010
BD¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·June 1, 2018
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024