609 results
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·December 31, 2025
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
FDA Enforcement
Class II
·Ongoing·Tenderneeds Fertility LLC·August 11, 2021
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025
MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light
FDA Enforcement
Class II
·Ongoing·MRIMed Inc.·March 4, 2026
EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·July 3, 2024
PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·July 3, 2024
MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·July 3, 2024
EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·July 3, 2024
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·July 3, 2024
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·July 3, 2024
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·July 3, 2024
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·July 3, 2024
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·July 3, 2024
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·July 3, 2024
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·July 3, 2024
Insufflation unit, UHI-4.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 3, 2024
EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·July 3, 2024