6 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·November 13, 2013
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
FDA Enforcement
Class II
·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·August 14, 2024
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·July 20, 2016
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026