3 results
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13ms
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Sources: EU EUDAMED, US FDA
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
FDA Recall
Open, Classified
·IPG Medical Corporation·Product code GEX·May 5, 2026
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography). Component: No
FDA Recall
Open, Classified
·Edan Diagnostics·Product code MHX·October 24, 2025
Integra Universal Flexible Arm part number REF 1362275
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code FXG·February 28, 2022