9 results · 22ms · Sources: EU EUDAMED, 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