Aomori Olympus Co., Ltd.
Aomori Olympus Co., Ltd. holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2005, with 113 FDA device recalls on record.
Top product codes for Aomori Olympus Co., Ltd.
FDA recalls by Aomori Olympus Co., Ltd.
10 most recent of 113- Z-2522-2023 — Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012
- Z-2523-2023 — 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
- Z-1054-2021 — NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
- Z-1063-2021 — PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
- Z-1036-2021 — NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
- Z-0970-2021 — K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
- Z-1005-2021 — INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
- Z-1069-2021 — NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the gastrointestinal tract.
- Z-0961-2021 — B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
- Z-1062-2021 — NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Aomori Olympus Co., Ltd.
- K042160 — SONOSURG TROCAR
- K041566 — SONOSURG ULTRASONIC SURGICAL SYSTEM
- K033333 — SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
- K031523 — OLYMPUS ULTRASONIC SURGICAL SYSTEM
- K031710 — OLYMPUS ULTRASONIC SURGICAL SYSTEM
- K021672 — PANCREATIC DRAINAGE TUBE
- K022446 — MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C
Data sourced from openFDA. This site is unofficial and independent of the FDA.