10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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Water Container (MAJ-901); Water Container (MAJ-902)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use Distal Cover MAJ-2315 (MAJ-2315)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Luer-Split MAJ-2092
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AUXILIARY WATER TUBE MAJ-855
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single-Use Biopsy Valve (MAJ-1555)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-664, MAJ-665, MAJ-666
FDA Enforcement
Class II
·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021