25 results
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40ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BriefCase
FDA 510(k)
FDA Class 2
·Radiology
MIS Lance+ Conical Connection Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
FDA 510(k)
FDA Class 2
·Radiology
GLP TRACK END
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·May 18, 2026
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 27, 2016
RAPIDPOINT 400
FDA Adverse Event
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.·Product code JGS·October 27, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 17, 2011
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·July 9, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 23, 2015
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 25, 2012
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·August 13, 2015
GLP CENTRIFUGE MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·July 10, 2025
GLP CENTRIFUGE MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·December 27, 2024
GLP CENTRIFUGE MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·April 28, 2025
GLP ALIQUOT MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·August 1, 2025
GLP TRACK END
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·April 1, 2026
NANOZOOMER S360 (THIS IS AN IVDD PRODUCT, NOT SOLD IN THE U.S.)
FDA Adverse Event
Malfunction
·HAMAMATSU PHOTONICS K.K, SYSTEMS DIVISION,·Product code PSY·June 5, 2023
GLP TRACK END
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·November 14, 2024
GLP CENTRIFUGE MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·December 27, 2024
GLP CENTRIFUGE MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·June 19, 2025