7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT
FDA 510(k)
FDA Class 2
·Dental
MITEK QUICKANCHOR(TM), MODIFICATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PERCUTANEOUS GUIDEWIRE PLACEMENT SYRINGE 50505
FDA 510(k)
FDA Class 2
·Cardiovascular
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·February 11, 2013
RIATA PASSIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·July 24, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021