7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXPIRATORY BREATHING EXERCISER
FDA 510(k)
FDA Class 2
·Anesthesiology
EN TYPING CIE KIT FOR DIAGNOSTIC USE
FDA 510(k)
FDA Class 2
·Immunology
PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE
FDA 510(k)
FDA Class 2
·Ophthalmic
SYNCHRON® CX3 DELTA CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJF·January 3, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 18, 2014
5MM MONOPOLAR HANDLE 33CM
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code KOG·December 27, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021