13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VESTIBULAR ANALYSIS APPARATUS
FDA 510(k)
FDA Unclassified
·Unknown
Aequalis™ Adjustable Reversed
FDA UDI
TORNIER, INC.·00846832068234·
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·September 10, 2024
ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
DIGITAL FLAT PANEL X-RAY DETECTOR
FDA 510(k)
FDA Class 2
·Radiology
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·April 29, 2014
CONTOUR
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 5, 2019
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014
HEARTMATE II LVAD
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·May 15, 2013
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 2, 2011
EGIA 45 ARTICULATING MED/THICK SULU
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·December 9, 2015
Artis Q biplane, Model Number 10848282
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012