8 results
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59ms
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Sources: EU EUDAMED, US FDA
regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle soft, Rx. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·October 14, 2015
regard Item Number: 800422001, Sterile, OR0491A - Arthroscopy Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·October 14, 2015
regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle soft, Rx. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015
regard Item Number: 800422001, Sterile, OR0491A - Arthroscopy Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015
PROXIMATE*PLUS MD SKIN STPLR
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDT·April 1, 2019
regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJH·October 20, 2022
regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJH·October 20, 2022
regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJH·October 20, 2022