Aomori Olympus Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
113
510(k) Clearances
7
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2523-2023Class IIReusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588July 27, 2023
Z-2522-2023Class IIOlympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal endJuly 27, 2023
Z-0994-2021Class IIINJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - Product Usage: Used with endoscopes tJanuary 4, 2021
Z-1063-2021Class IIPBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscoJanuary 4, 2021
Z-1069-2021Class IINA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasoJanuary 4, 2021
Z-0961-2021Class IIB5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medJanuary 4, 2021
Z-0992-2021Class IISD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - Product Usage: Used with endoscopesJanuary 4, 2021
Z-1015-2021Class IIINJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes tJanuary 4, 2021
Z-0991-2021Class IISD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: Used with endoscopesJanuary 4, 2021
Z-0967-2021Class IIB-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Used with endoscopes toJanuary 4, 2021
Z-1059-2021Class IINA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultJanuary 4, 2021
Z-1002-2021Class IIINJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perJanuary 4, 2021
Z-1040-2021Class IINEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to performJanuary 4, 2021
Z-1006-2021Class IIINJECTOR FORCEMAX LOWER 23G 6MM, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perJanuary 4, 2021
Z-1007-2021Class IIINJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perJanuary 4, 2021
Z-1062-2021Class IINA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product UsageJanuary 4, 2021
Z-1026-2021Class IIINJECTOR FORCEMAX UP 2MM CH 23G 3MM, model no. NM-401L-0523 - Product Usage: Used with endoscopes toJanuary 4, 2021
Z-1020-2021Class IIINJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - Product Usage: Used with endoscopes tJanuary 4, 2021
Z-1043-2021Class IINEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used with endoscopes to performJanuary 4, 2021
Z-1054-2021Class IINA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collJanuary 4, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K042160SONOSURG TROCARJanuary 25, 2005
K041566SONOSURG ULTRASONIC SURGICAL SYSTEMSeptember 8, 2004
K033333SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-BNovember 14, 2003
K031523OLYMPUS ULTRASONIC SURGICAL SYSTEMOctober 1, 2003
K031710OLYMPUS ULTRASONIC SURGICAL SYSTEMAugust 29, 2003
K021672PANCREATIC DRAINAGE TUBEApril 16, 2003
K022446MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402CMarch 28, 2003