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-1013-2021Class IIINJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes tJanuary 4, 2021
Z-0969-2021Class IIPR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrasJanuary 4, 2021
Z-0966-2021Class IIB-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with endoscopes toJanuary 4, 2021
Z-1024-2021Class IIINJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-0423 - Product Usage: Used with endoscopes toJanuary 4, 2021
Z-0981-2021Class IIKD-650U ELECTROSURGICAL SNARE, model no. KD-650U - Product Usage: Used with endoscopes and electrosuJanuary 4, 2021
Z-1057-2021Class IINA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collJanuary 4, 2021
Z-0990-2021Class IISD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with endoscopes to elecJanuary 4, 2021
Z-0968-2021Class IIB-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes toJanuary 4, 2021
Z-1044-2021Class IINEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with endoscopes to performJanuary 4, 2021
Z-1033-2021Class IINEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used with endoscopes to performJanuary 4, 2021
Z-1035-2021Class IINEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with endoscopes to performJanuary 4, 2021
Z-1050-2021Class IIK-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cellsJanuary 4, 2021
Z-1064-2021Class IIPBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopJanuary 4, 2021
Z-0982-2021Class IIKD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endoscopes and electrosuJanuary 4, 2021
Z-1040-2021Class IINEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - 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
Z-1063-2021Class IIPBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscoJanuary 4, 2021
Z-0976-2021Class IIKD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with endoscopes and electrosuJanuary 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