18 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
FDA Enforcement
Class II
·Ongoing·Medtronic Sofamor Danek USA Inc·November 1, 2023
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·August 21, 2024
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
FDA Enforcement
Class II
·Ongoing·Klinika Mdical Gmb·May 21, 2025
KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
FDA Enforcement
Class II
·Ongoing·Klinika Mdical Gmb·May 21, 2025
Radiography 7300 C; Model Number: 712037;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025
CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022
ProxiDiagnost N90. radiography and fluoroscopy system
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022
CombiDiagnost R90 Software Version R1.0 and R1.1
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Gmbh, DMC·September 8, 2021
DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022
DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022
DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022
CombiDiagnost R90; Model Number: 709031;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025
DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025
Precision CRF; Model Number: 706400;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025
ProxiDiagnost N90; Model Number: 706110;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025