7 results
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17ms
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Sources: EU EUDAMED, US FDA
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Country: China
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Nox Bellcow Cosmetics Co., Ltd.
Manufacturer
🇨🇳 China
Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)
FDA 510(k)
FDA Class 2
·Radiology
Lux HD 2530 detector (Lux HD 2530)
FDA 510(k)
FDA Class 2
·Radiology
GE Carestation 30 anesthesia systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems China Co., Ltd.·September 5, 2018
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.
FDA Enforcement
Class II
·Ongoing·MAX LUX CORP·December 8, 2021
GE 9100c NXT anesthesia systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems China Co., Ltd.·September 5, 2018
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems China Co., Ltd.·September 5, 2018