8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Arthrex®
FDA UDI
ARTHREX, INC.·00888867133594·JOYSTICK, PERCUTANEOUS GUIDE
SPQ(TM) ANTIBODY REAGENT SET II FOR C3
FDA 510(k)
FDA Class 1
·Immunology
PATIENT EXAMINATION GLOVES (LATEX)
FDA 510(k)
FDA Class 1
·General Hospital
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·June 25, 2014
DREAMTOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNS·November 10, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 3, 2013
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020