21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
FDA Enforcement
Class II
·Completed·Beckman Coulter Mishima K.K.·June 11, 2025
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
FDA Enforcement
Class II
·Completed·Beckman Coulter Mishima K.K.·June 11, 2025
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.
FDA Enforcement
Class II
·Terminated·Mani, Inc. - Kiyohara Facility·May 3, 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
FDA Enforcement
Class II
·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023
Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
FDA Enforcement
Class II
·Terminated·Dentech Corp.·June 2, 2021
Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
FDA Enforcement
Class II
·Terminated·Asahi Kasei Medical Co., Ltd., Okatomi Plant·September 26, 2012
Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
FDA Enforcement
Class II
·Terminated·Asahi Kasei Medical Co., Ltd., Okatomi Plant·September 26, 2012
Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
FDA Enforcement
Class II
·Terminated·Asahi Kasei Medical Co., Ltd., Okatomi Plant·September 26, 2012
Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter
FDA Enforcement
Class II
·Terminated·Asahi Kasei Medical Co., Ltd., Okatomi Plant·September 26, 2012
Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
FDA Enforcement
Class II
·Terminated·Asahi Kasei Medical Co., Ltd., Okatomi Plant·September 26, 2012
Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
FDA Enforcement
Class II
·Terminated·Asahi Kasei Medical Co., Ltd., Okatomi Plant·September 26, 2012
Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
FDA Enforcement
Class II
·Terminated·Asahi Kasei Medical Co., Ltd., Okatomi Plant·September 26, 2012
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
FDA Enforcement
Class II
·Ongoing·Orthorebirth Co Ltd·May 13, 2026
Pathfast D-Dimer, Reference number: PF1051-KUS
FDA Enforcement
Class II
·Terminated·Lsi Medience Corporation·November 30, 2016
Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
FDA Enforcement
Class II
·Terminated·Atom Medical Corporation·July 18, 2012
MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
FDA Enforcement
Class II
·Terminated·Mani, Inc. - Kiyohara Facility·December 16, 2020
MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S
FDA Enforcement
Class II
·Terminated·Mani, Inc. - Kiyohara Facility·December 16, 2020
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
FDA Enforcement
Class II
·Ongoing·Orthorebirth Co Ltd·May 13, 2026
SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
FDA Enforcement
Class II
·Terminated·Akita Sumitomo Bakelite Co., Ltd.·November 16, 2016
SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
FDA Enforcement
Class II
·Terminated·Akita Sumitomo Bakelite Co., Ltd.·November 16, 2016