8 results
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19ms
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Sources: EU EUDAMED, US FDA
DIGENE DCR-1 LUMINOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PM2 System and ECGuide Connector
FDA 510(k)
FDA Class 2
·General Hospital
MEDIPACS
FDA 510(k)
FDA Class 2
·Radiology
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·February 4, 2013
UNKNOWN ZIMMER HIP
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDI·December 21, 2010
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 18, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020