13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARROW RADIAL ARTERY CATHETERIZATION SET
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Zimmer, Inc.·00889024273788·
SOLERO
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code NEY·June 11, 2024
ENSIL FABRIC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EASYRA UREA NITROGEN AND CREATININE REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PI CVC KIT: 3-L FR X 20 CM AGB
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code FOZ·March 24, 2014
CAPSURE Z NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
ARROW BLUE PLUS PRESSURE INJECTABLE TRIPLE-LUMEN CVC
FDA Adverse Event
Malfunction
·ARROW/TELEFLEX MEDICAL·Product code FOZ·August 16, 2010
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 11, 2019
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·July 20, 2016
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·July 20, 2016
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
FDA Recall
Terminated
·Arrow International Inc·Product code DQX·June 2, 2016
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
FDA Recall
Terminated
·Arrow International Inc·Product code DQX·June 2, 2016