7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONOJECT BONE MARROW BIOPSY TRAYS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PATIENT EXAMINATION GLOVE/HYPOALLERGENIC
FDA 510(k)
FDA Class 1
·General Hospital
RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
ARTISTE MV SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY·Product code IYE·December 28, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 18, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NEK·January 3, 2011
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