14 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A VST60SF ARDVST229036A VST66SF ARDVST229037A VST66DF
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·July 6, 2022
The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, efficiency, and reliability in their layout tasks. The integrated Class 2 green aiming laser system enhances visibility and accuracy, even on uneven surfaces. It is ideal for general and specialty contractors, the RTS873 streamlines layout processes, reduces rework, and enhances overall productivity.
FDA Enforcement
Class II
·Ongoing·Trimble Ab·May 7, 2025
AIM-V Medium REF AV.200/500
FDA Enforcement
Class II
·Ongoing·OXFORD IMMUNOTEC LTD·September 7, 2022
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·August 2, 2023
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·August 2, 2023
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·August 2, 2023
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·August 2, 2023
Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·August 2, 2023
Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·August 2, 2023
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·August 2, 2023
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.
FDA Enforcement
Class II
·Ongoing·Hologic, Inc·May 6, 2026
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component
FDA Enforcement
Class II
·Ongoing·Dentsply IH, Inc.·September 3, 2025
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component
FDA Enforcement
Class II
·Ongoing·Dentsply IH, Inc.·September 3, 2025
Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.
FDA Enforcement
Class III
·Ongoing·AMS Diagnostics, LLC·July 19, 2017