7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACID REAGENT, URIC SINGLE VIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MATRx Plus
FDA 510(k)
FDA Class 2
·Anesthesiology
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·April 30, 2014
BEAVER ARTHRO-LOK BANANA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GES·September 27, 2012
HARMONIC ACE 36CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·January 24, 2008
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