63 results
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Sources: EU EUDAMED, US FDA
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Country: Spain
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SEDECAL S.A.
FDA registration
SEDECAL S.A.·9 products·🇪🇸 Spain
SEDECAL, S.A. (SOCIEDAD ESPAÑOLA DE ELECTROMEDICINA Y CALIDAD, S.A.)
Manufacturer
🇪🇸 Spain
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
FDA 510(k)
FDA Class 2
·Radiology
Sedecal NOVA FA DR System. for diagnostic radiography.
FDA Enforcement
Class II
·Ongoing·Sedecal S.A.·November 28, 2018
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·November 16, 2022
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·January 31, 2024
Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·March 8, 2023
SM_40HF_BDC3, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
SM_40HF_BDC, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
SM_40HF_B_D_VIR3.004, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
SHIMADZU RF.004, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number 40KWMOBILE3.899, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
SED URS LP, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number 40KWFXPLUS.889, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number 40KW-FX.899, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number 40KWFXPLUS.004, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025