21 results
·
9ms
·
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
COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S
FDA Enforcement
Class II
·Terminated·Wilson-Cook Medical Inc.·February 6, 2019
COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
FDA Enforcement
Class II
·Terminated·Wilson-Cook Medical Inc.·February 6, 2019
DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN DCF-A2463EN DCF-E2460DE DCF-E2460EN DCF-E2460FR DCF-E2460TH UDI 00815098020287, 00815098020317 Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
FDA Enforcement
Class II
·Terminated·Defibtech, LLC·June 24, 2020
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
DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DCF-C2310EN DCF-E2310CA DCF-E2310EN UDI 00815098020201, 00815098020225, 00815098020232 Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
FDA Enforcement
Class II
·Terminated·Defibtech, LLC·June 24, 2020
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