252 results
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12ms
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Sources: EU EUDAMED, US FDA
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
Philips DuraDiagnost stationary X-ray system
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·September 7, 2016
Bodor's I series laser cutting machine.
FDA Enforcement
Class II
·Ongoing·Jinan Bodor Cnc Machine Co Ltd·July 30, 2025
Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
FDA Enforcement
Class II
·Terminated·Chicago X-Ray Systems, Inc.·May 29, 2013
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
LightPod ERA lasers
FDA Enforcement
Class II
·Terminated·Aerolase Corporation·January 15, 2020
LightPod Neo Lasers
FDA Enforcement
Class II
·Terminated·Aerolase Corporation·January 15, 2020
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
FDA Enforcement
Class II
·Terminated·Fujifilm Medical System USA, Inc.·May 28, 2014
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