7 results
·
6ms
·
Sources: EU EUDAMED, US FDA
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.
FDA Enforcement
Class II
·Ongoing·Breas Medical, Inc.·December 6, 2023
BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog # 20062E; BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog # 70000N-07; BD MaxGuardTM tri-fuse extension set, Catalog # ME1224; BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog # 20350ET; BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog # 70001B-07T.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·November 29, 2023
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
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
FDA Enforcement
Class II
·Ongoing·Human Care Hc Sweden Ab·April 17, 2024