3 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site
FDA Enforcement
Class II
·Ongoing·Genicon, Inc.·October 21, 2020
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·February 2, 2022
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·February 2, 2022