4 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology
FDA Enforcement
Class II
·Terminated·Kreg Medical Inc.·June 12, 2013
Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care.
FDA Enforcement
Class II
·Terminated·Resmed Corporation·February 10, 2016
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025