16 results
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15ms
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Sources: EU EUDAMED, US FDA
Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) PUTTY T50106INT GRAFTON DBF 6CC, REF T50106INT; Demineralized Bone Matrix (DBM) product
FDA Enforcement
Class II
·Ongoing·Medtronic Sofamor Danek USA Inc·April 12, 2023
Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310E3/1¿(German/French dual language), DCF-E2310F3/1¿ (French/English dual language), DCF-E2310G3/1¿(French/German dual language), DCF-E2310IT (Italian language)
FDA Enforcement
Class II
·Ongoing·Defibtech, LLC·May 7, 2025
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product
FDA Enforcement
Class II
·Ongoing·Medtronic Sofamor Danek USA Inc·April 12, 2023
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)
FDA Enforcement
Class II
·Ongoing·Defibtech, LLC·May 7, 2025
Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Demineralized Bone Matrix (DBM) product
FDA Enforcement
Class II
·Ongoing·Medtronic Sofamor Danek USA Inc·April 12, 2023
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
FDA Enforcement
Class II
·Ongoing·Defibtech, LLC·May 7, 2025
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
FDA Enforcement
Class II
·Ongoing·Defibtech, LLC·May 7, 2025
Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·June 22, 2022
Model No. CYF-5, Cystonephrofiberscope
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Model No. CYF-5R, Cystonephrofiberscope
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
FDA Enforcement
Class II
·Ongoing·Defibtech, LLC·May 7, 2025