66 results
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7ms
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Sources: EU EUDAMED, US FDA
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 1, 2022
Kit BD Max ExK TNA 2; Catalog # 442825
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 1 USA; Catalog # 442817
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 2 USA; Catalog # 442819
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·November 19, 2025
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
ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Enforcement
Class II
·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Enforcement
Class II
·Terminated·Implant Direct Sybron Manufacturing, LLC·October 9, 2019
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Enforcement
Class II
·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020
Artix MT Thrombectomy Device, REF: 32-102
FDA Enforcement
Class II
·Ongoing·Inari Medical - Oak Canyon·May 14, 2025
CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 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.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 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.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021