Aomori Olympus Co., Ltd.
Medical device manufacturer in Kuroishi, 2 Chome, Japa.
7510(k) clearances
0PMA approvals
113recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K042160 | Sonosurg TrocarLFL · Traditional | 01/25/2005SE |
| K041566 | Sonosurg Ultrasonic Surgical SystemLFL · Traditional | 09/08/2004SE |
| K033333 | Single Use 3-LUMEN Balloon Catheter, Models B-230Q-A and B-230Q-BFGE · Special | 11/14/2003SE |
| K031523 | Olympus Ultrasonic Surgical SystemLFL · Traditional | 10/01/2003SE |
| K031710 | Olympus Ultrasonic Surgical SystemLFL · Traditional | 08/29/2003SE |
| K021672 | Pancreatic Drainage TubeFGE · Traditional | 04/16/2003SE |
| K022446 | Mucus Collection Probe, Models BC-401C & BC-402CEOQ · Traditional | 03/28/2003SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2523-2023 Class II | Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483…The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level… | 07/27/2023Open, Classified |
| Z-2522-2023 Class II | Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to…The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level… | 07/27/2023Open, Classified |
| Z-1071-2021 Class II | CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1070-2021 Class II | CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1069-2021 Class II | NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1068-2021 Class II | MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage:…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1067-2021 Class II | MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage:…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1066-2021 Class II | PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1065-2021 Class II | PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1064-2021 Class II | PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1063-2021 Class II | PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1062-2021 Class II | NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C -…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1061-2021 Class II | NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1060-2021 Class II | NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage:…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1059-2021 Class II | NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage:…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1058-2021 Class II | NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1057-2021 Class II | NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1056-2021 Class II | NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1055-2021 Class II | NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1054-2021 Class II | NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1053-2021 Class II | K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1052-2021 Class II | K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1051-2021 Class II | K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1050-2021 Class II | K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1049-2021 Class II | NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1048-2021 Class II | NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1047-2021 Class II | NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1046-2021 Class II | NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1045-2021 Class II | NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1044-2021 Class II | NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1043-2021 Class II | NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1042-2021 Class II | NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1041-2021 Class II | NEEDLEMASTER 3MMx 26G LOWER, model no. NM-610U-0326 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1040-2021 Class II | NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1039-2021 Class II | NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1038-2021 Class II | NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1037-2021 Class II | NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1036-2021 Class II | NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1035-2021 Class II | NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1034-2021 Class II | NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1033-2021 Class II | NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1032-2021 Class II | NEEDLEMASTER 4MMx 25G UPPER, model no. NM-610L-0425 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1031-2021 Class II | NEEDLEMASTER 4MMx 23G UPPER, model no. NM-610L-0423 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1030-2021 Class II | NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1029-2021 Class II | INJECTOR FORCEMAX UP 2MM CH 25G 6MM, model no. NM-401L-0625 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1028-2021 Class II | INJECTOR FORCEMAX UP 2MM CH 23G 6MM, model no. NM-401L-0623 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1027-2021 Class II | INJECTOR FORCEMAX UP 2MM CH 25G 5MM, model no. NM-401L-0525 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1026-2021 Class II | INJECTOR FORCEMAX UP 2MM CH 23G 3MM, model no. NM-401L-0523 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1025-2021 Class II | INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1024-2021 Class II | INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-0423 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1023-2021 Class II | INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1022-2021 Class II | INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1021-2021 Class II | INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1020-2021 Class II | INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1019-2021 Class II | INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1018-2021 Class II | INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1017-2021 Class II | INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1016-2021 Class II | INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1015-2021 Class II | INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1014-2021 Class II | INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1013-2021 Class II | INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1012-2021 Class II | INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1011-2021 Class II | INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1010-2021 Class II | INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1009-2021 Class II | INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1008-2021 Class II | INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1007-2021 Class II | INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1006-2021 Class II | INJECTOR FORCEMAX LOWER 23G 6MM, model no. NM-400U-0623 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1005-2021 Class II | INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1004-2021 Class II | INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1003-2021 Class II | INJECTOR FORCEMAX LOWER 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1002-2021 Class II | INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1001-2021 Class II | INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-1000-2021 Class II | INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0999-2021 Class II | INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0998-2021 Class II | INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0997-2021 Class II | INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0996-2021 Class II | INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0995-2021 Class II | INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0994-2021 Class II | INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0993-2021 Class II | INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0992-2021 Class II | SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - Product Usage: Used…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0991-2021 Class II | SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: Used…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0990-2021 Class II | SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0989-2021 Class II | SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0988-2021 Class II | SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0987-2021 Class II | SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0986-2021 Class II | SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage: Used with endoscopes to…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0985-2021 Class II | SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - Product Usage: Used with endoscopes to…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0984-2021 Class II | SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0983-2021 Class II | KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - Product Usage: Used with endoscopes…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0982-2021 Class II | KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endoscopes…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0981-2021 Class II | KD-650U ELECTROSURGICAL SNARE, model no. KD-650U - Product Usage: Used with endoscopes…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0980-2021 Class II | KD-650L ELECTROSURGICAL SNARE, model no. KD-650L - Product Usage: Used with endoscopes…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0979-2021 Class II | KD-640L ELECTROSURGICAL SNARE, model no. KD-640L - Product Usage: Used with endoscopes…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0978-2021 Class II | KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with endoscopes…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0977-2021 Class II | KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - Product Usage: Used with endoscopes…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0976-2021 Class II | KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with endoscopes…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0975-2021 Class II | KD-612L ELECTROSURGICAL KNIFE, model no. KD-612L - Product Usage: Used with endoscopes…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0974-2021 Class II | KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with endoscopes…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0973-2021 Class II | K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0972-2021 Class II | K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0971-2021 Class II | K-202 GUIDE SHEATH Kit 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0970-2021 Class II | K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0969-2021 Class II | PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0968-2021 Class II | B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0967-2021 Class II | B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0966-2021 Class II | B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0965-2021 Class II | B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0964-2021 Class II | B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0963-2021 Class II | B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0962-2021 Class II | B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |
| Z-0961-2021 Class II | B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | 01/04/2021Terminated |