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-1063-2021Class IIPBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscoJanuary 4, 2021
Z-1005-2021Class IIINJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perJanuary 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-0993-2021Class IIINJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes tJanuary 4, 2021
Z-1056-2021Class IINA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with endoscopes to collJanuary 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-0970-2021Class IIK-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cellsJanuary 4, 2021
Z-1039-2021Class IINEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used with endoscopes to performJanuary 4, 2021
Z-0964-2021Class IIB7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injJanuary 4, 2021
Z-0980-2021Class IIKD-650L ELECTROSURGICAL SNARE, model no. KD-650L - Product Usage: Used with endoscopes and electrosuJanuary 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-1002-2021Class IIINJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perJanuary 4, 2021
Z-1048-2021Class IINEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to performJanuary 4, 2021
Z-1040-2021Class IINEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to performJanuary 4, 2021
Z-1036-2021Class IINEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with endoscopes to performJanuary 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