10 results
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18ms
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Sources: EU EUDAMED, US FDA
400T ECT SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
ROCHE COBAS TAQMAN ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PLANET Onco Dose
FDA 510(k)
FDA Class 2
·Radiology
SELOX ST 53
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·May 15, 2014
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·October 31, 2012
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 2, 2015
RX PERMANENT PACING LEAD
FDA Adverse Event
Injury
·OSCOR INC.·Product code DTB·November 19, 2021
DRILL BIT Ø2.5 L110/85 2FLUTE F/QC
FDA Adverse Event
Malfunction
·Product code HTW·July 1, 2021
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781346 & 8) Achieva 1.5T Model 781382 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·April 25, 2018
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781346 & 8) Achieva 1.5T Model 781382 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code LNH·March 16, 2018