896 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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ACCUWELL TSH, MODEL KAW-TSH-960
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Oxygen Concentrator, Model JAY-5AW
FDA 510(k)
FDA Class 2
·Anesthesiology
ALIGNRT
FDA 510(k)
FDA Class 2
·Radiology
EXALIS, SOFTWARE VERSION 1.15
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MOLECULAR ADSORBENT RECIRCULATING(MARS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRISMAFLEX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PHOENIX HEMODIALYSIS DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRISMAFLEX SYSTEM 7.10
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRISMAFLEX M150 SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SNORKEL
FDA 510(k)
FDA Class 2
·Dental
ATG/SM-OSA APPLIANCES
FDA 510(k)
FDA Class 2
·Dental
FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
FDA 510(k)
FDA Class 2
·Dental