9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KODAK EKTACHEM 250 ANALYER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THERMAL SENSORY ANALYZER (TSA-II)
FDA Adverse Event
Injury
·MEDOC LTD., ADVANCED MEDICAL SURGERY MEDISCENSE USA·Product code LQW·December 26, 2019
SPINAL ANES/EPIDURAL CAT H KIT
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code CAZ·January 15, 2013
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·July 9, 2014
QSENSE CPM THERMAL SENSORY ANALYZER 2001
FDA Adverse Event
Malfunction
·MEDOC LTD, ADVANCED MEDICAL SYSTEM·Product code LQW·April 19, 2022
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021