15 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Q-Rejuvalight Pro Facewear (Model: P19-0023)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LessRay
FDA UDI
Nuvasive, Inc.·00887517976062·LessRay Extension, Table Array
Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
FDA Pre-Market Approval
FDA Class 3
·Optune Lua
PREMIER III PHASED ARRAY CTL SPINE COIL
FDA 510(k)
FDA Class 2
·Radiology
CO2 Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
FDA Pre-Market Approval
FDA Class 3
·Optune Lua
Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
FDA Pre-Market Approval
FDA Class 3
·Optune Lua®
Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
FDA Pre-Market Approval
FDA Class 3
·Optune Lua®
Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
FDA Pre-Market Approval
FDA Class 3
·Optune Lua
Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
FDA Pre-Market Approval
FDA Class 3
·Optune Lua®
FG 6301 DUAL CHNL VOL INF PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 17, 2008
CAPSURE Z NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 31, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 16, 2013
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·April 19, 2023
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025