7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOSKINS NYLON SUTURE LASER LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
FLEET DETECTATEST
FDA 510(k)
FDA Class 2
·Hematology
125I-TESTOSTERONE TEST SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 22, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code IOR·December 10, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 23, 2015
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020