5 results
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45ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S
FDA Enforcement
Class II
·Ongoing·Sarnova HC, Llc·March 27, 2024
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
FDA Enforcement
Class II
·Ongoing·Sarnova HC, Llc·March 27, 2024
Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
FDA Enforcement
Class II
·Ongoing·Sarnova HC, Llc·January 24, 2024
Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
FDA Enforcement
Class II
·Ongoing·Sarnova HC, Llc·January 24, 2024