9 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DSL AACTIVE DHEA EIA KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Zuma™
FDA UDI
Seaspine Orthopedics Corporation·10889981037581·Trial, 26mm x 24mm x 14mm, 8 Deg. Zuma™ Trials ...
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221117557·3M™ Victory Series™ Second Molar Bands, 955-114...
GUIDE WIRE EXTENSION
FDA 510(k)
FDA Class 2
·Cardiovascular
A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER
FDA 510(k)
FDA Class 2
·Cardiovascular
S-ROM*SLEEVE PRX ZTT, 18D-SML
FDA Adverse Event
Injury
·DEPUY IRELAND ¿ REG. # 9616671·Product code LPH·February 11, 2013
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code LHI·July 24, 2014
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·January 10, 2011
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