8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANTISERUM TO HUMAN APOLIPOPROTEIN B
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TRIAGE CARDIO PROFILER PANEL
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC·Product code MMI·July 12, 2012
Penumbra System (Thunderbolt Aspiration Tubing)
FDA 510(k)
FDA Class 2
·Cardiovascular
CONNEXUS
FDA 510(k)
FDA Class 2
·Orthopedic
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 21, 2014
HIRES 90K IMPLANT
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·November 20, 2012
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 17, 2015
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015