12 results
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8ms
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Sources: EU EUDAMED, US FDA
Burlington Medical, Frontal Aprons
FDA Enforcement
Class II
·Ongoing·Burlington Medical, LLC·April 8, 2026
Burlington Medical, Kilt
FDA Enforcement
Class II
·Ongoing·Burlington Medical, LLC·April 8, 2026
Burlington Medical, Wrap Aprons.
FDA Enforcement
Class II
·Ongoing·Burlington Medical, LLC·April 8, 2026
Burlington Medical, Vest
FDA Enforcement
Class II
·Ongoing·Burlington Medical, LLC·April 8, 2026
Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.
FDA Enforcement
Class II
·Ongoing·Burlington Medical, LLC·April 8, 2026
DxM 1040 MicroScan WalkAway Instrument REF B1018-440
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·May 25, 2022
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·May 25, 2022
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·January 8, 2025
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
FDA Enforcement
Class II
·Ongoing·FX SHOULDER·February 7, 2024
Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
FDA Enforcement
Class II
·Terminated·Fx Solutions·July 25, 2018
Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
FDA Enforcement
Class II
·Terminated·Fx Solutions·July 25, 2018
CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO 3 V1.05 System is also intended to support EP procedures, maintaining CARTO¿ XP System capabilities, in the presence of a high metallic environment and provide a data communication channel to the Stereotaxis Niobe Catheter Guidance System as well as in a regular EP lab. The CARTO 3 V1.05 System includes the CartoMerge capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and real time catheter navigation, the Fast Anatomical Mapping (FAM) functionality, enabling creation of cardiac maps using'catheters with magnetic proximal and distal location sensors and the CartoSound image integration functionality, that enables integration of intracardiac echo (ICE) visualization to provide 3D combined maps. In addition to the use of specialized navigation catheters, the system is also intended for use with non-navigational electrophysiology catheters.
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·September 19, 2012