10 results
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29ms
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Sources: EU EUDAMED, US FDA
OXYGEN RICH AIR SUPPLY UNIT-MODEL 390
FDA 510(k)
FDA Class 2
·Anesthesiology
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Simple Science Antimicrobial Facial and Eyelid Cleanser
FDA 510(k)
FDA Unclassified
·Unknown
S4
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code LZS·April 30, 2014
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 10, 2012
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 25, 2007
Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging System
FDA Recall
Terminated
·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code LNH·December 21, 2018
Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Multiva 1.5T Model 781076, & 5) Multiva 1.5T 16ch R5 based Model 781078 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
Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Multiva 1.5T Model 781076, & 5) Multiva 1.5T 16ch R5 based Model 781078 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