10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PodSKAN HF Diagnostic X-ray System
FDA 510(k)
FDA Class 2
·Radiology
BD BBL™ Sensi-Disc™ Linezolid 30 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902317616·BD BBL™ Sensi-Disc™ Linezolid 30 µg
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776206949·Cannula Storz Scope Lock Style Dual Rotating St...
ELMED
FDA UDI
ELMED INCORPORATED·00842180148260·5.8MM, CANNULA, STRYKER SPEED LOCK STYLE, DUAL ...
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYNTHES (USA) NEW/STERIAL ORBITAL PLATES
FDA 510(k)
FDA Class 2
·Dental
UV FLASH TRANSFER SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 1, 2011
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·July 15, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022