4 results
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73ms
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Sources: EU EUDAMED, US FDA
Command Medical Products, LLC.
FDA registration
Command Medical Products, LLC.·30 products·🇺🇸 United States
REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
FDA Adverse Event
Malfunction
·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code FRN·September 13, 2023
VMX MOBILE X-RAY SYSTEM
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS, LLC·Product code IZL·February 13, 2012
AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number: 0070-1531, Catalog Numbers: 0070-1664,0070-1649,0070-1654: Version 3.67 0070-1721: Version 3.671 0070-1662: Version 3.67, US version; 0070-1668; IVersion 3.67 International version Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The WaveScan WaveFront System is a class III accessory device used in conjunction with the VISX STAR S4 and STAR S4 IRTM Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The WaveScan WaveFront System is a diagnostic instrument intended for the automated measurement, analysis, and recording of refractive errors of the eye. The WaveScan System software uses the diagnostic data of the eye's refractive errors and wavefront aberrations to calculate the target treatment shape and then generates the commands for the VISX STAR laser to create the target shape on the cornea.
FDA Recall
Terminated
·AMO Manufacturing USA, LLC·Product code LZS·July 13, 2010