8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCALEX 800
FDA 510(k)
FDA Class 2
·Dental
BASE
FDA UDI
Nuvasive, Inc.·00887517701657·BASE HL Trial, 8x34x24mm 20°
MICROZYME T3 ENZYME IMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RA 80 EIKEN
FDA 510(k)
FDA Class 2
·Immunology
VIRTUOSO DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LWS·February 11, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 10, 2011
SYMPHONY
FDA Adverse Event
Malfunction
·SORIN CRM·Product code NVZ·July 24, 2014
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021