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For more information, please visit the National Center for Medical Devices and Products Reporting Click Here
Title Date File
The medical device does not have Medical Devices Marketing Authorization (MDMA) 2025-10-14
Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices 2025-10-14
(WU2542) NCMDR Weekly Update 2025-10-12
(WU2541) NCMDR Weekly Update 2025-10-05
(WU2540) NCMDR Weekly Update 2025-09-28
(WU2539) NCMDR Weekly Update 2025-09-21
(WU2538) NCMDR Weekly Update 2025-09-14
A wiring problem with the speaker. This may result in a failure which will appear on the pump screen as Malfunction Code 16-0x20E6, also known as “Malfunction 16”. 2025-09-10
(WU2536) NCMDR Weekly Update 2025-08-31
(WU2535) NCMDR Weekly Update 2025-08-25
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