132 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
FDA Enforcement
Class II
·Ongoing·Beyond Laser Systems, LLC·July 23, 2025
Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.
FDA Enforcement
Class II
·Ongoing·Beyond Laser Systems, LLC·July 23, 2025
Laser light show projectors manufactured by BLS, Model PURE 5000/10000.
FDA Enforcement
Class II
·Ongoing·Beyond Laser Systems, LLC·July 23, 2025
Bodor's I series laser cutting machine.
FDA Enforcement
Class II
·Ongoing·Jinan Bodor Cnc Machine Co Ltd·July 30, 2025
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
FDA Enforcement
Class II
·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
FDA Enforcement
Class II
·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
FDA Enforcement
Class II
·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025
Material Processing Laser Products
FDA Enforcement
Class II
·Ongoing·SHENZHEN ATOMSTACK TECHNOLOGIES·January 7, 2026
Beijing Syntech Laser UL Station surgical lasers
FDA Enforcement
Class II
·Ongoing·Beijing Syntech Laser Co., Ltd·May 9, 2018
Beijing Syntech Laser Diode Laser surgical lasers
FDA Enforcement
Class II
·Ongoing·Beijing Syntech Laser Co., Ltd·May 9, 2018
Beijing Syntech Laser UL C02 Laser surgical lasers
FDA Enforcement
Class II
·Ongoing·Beijing Syntech Laser Co., Ltd·May 9, 2018
Beijing Syntech Laser Trixel C02 Laser surgical lasers
FDA Enforcement
Class II
·Ongoing·Beijing Syntech Laser Co., Ltd·May 9, 2018
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 17, 2025
Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
FDA Enforcement
Class II
·Ongoing·Beijing Syntech Laser Co., Ltd·May 9, 2018
Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers
FDA Enforcement
Class II
·Ongoing·Beijing Syntech Laser Co., Ltd·May 9, 2018
Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers
FDA Enforcement
Class II
·Ongoing·Beijing Syntech Laser Co., Ltd·May 9, 2018
Beijing Syntech Laser Nice Station Light Based Platform surgical lasers
FDA Enforcement
Class II
·Ongoing·Beijing Syntech Laser Co., Ltd·May 9, 2018
KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024
KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024
KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024