9 results
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47ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POM Medical, LLC
FDA registration
POM Medical, LLC·1 product·🇺🇸 United States
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.
FDA Enforcement
Class II
·Terminated·POM Medical LLC·November 6, 2019
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.
FDA Recall
Terminated
·POM Medical LLC·Product code BYG·July 11, 2018
POM
FDA Adverse Event
Malfunction
·POM MEDICAL, LLC.·Product code BYG·August 14, 2018
POM
FDA Adverse Event
Malfunction
·POM MEDICAL, LLC.·Product code BYG·August 14, 2018
POM
FDA Adverse Event
Malfunction
·POM MEDICAL, LLC.·Product code BYG·August 14, 2018
POM
FDA Adverse Event
Malfunction
·POM MEDICAL, LLC.·Product code BYG·August 14, 2018
CURAPLEX / POM
FDA Adverse Event
Malfunction
·POM MEDICAL, LLC.·Product code BYG·August 14, 2018
POM
FDA Adverse Event
Malfunction
·POM MEDICAL, LLC.·Product code BYG·August 14, 2018