95 results
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13ms
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Sources: EU EUDAMED, US FDA
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 Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code HAW·November 12, 2025
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
FDA Recall
Open, Classified
·Tenderneeds Fertility LLC·Product code MQF·December 23, 2020
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code GKZ·August 13, 2025
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code GKZ·August 13, 2025
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code GKZ·August 13, 2025
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code GKZ·August 13, 2025
#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code CCW·May 17, 2022
Puritan Bennett 980 Series Ventilator
FDA Recall
Open, Classified
·Medtronic formerly Covidien Michael Collins Road, Mervue Ind. Park Galway Ireland·Product code CBK·March 25, 2022
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 Recall
Open, Classified
·MRIMed Inc.·Product code KZF·October 13, 2025
Mobilett Mira wireless (VA20) mobile x-ray system(s)
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code IZL·October 5, 2023
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
FDA Recall
Open, Classified
·Medtronic Inc.·Product code LWS·April 16, 2024
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
FDA Recall
Open, Classified
·Medtronic Inc.·Product code LWS·April 16, 2024
MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
FDA Recall
Open, Classified
·Medtronic Inc.·Product code LWS·April 16, 2024
PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
FDA Recall
Open, Classified
·Medtronic Inc.·Product code LWS·April 16, 2024
PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
FDA Recall
Open, Classified
·Medtronic Inc.·Product code LWS·April 16, 2024
MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
FDA Recall
Open, Classified
·Medtronic Inc.·Product code LWS·April 16, 2024
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
FDA Recall
Open, Classified
·Medtronic Inc.·Product code LWS·April 16, 2024
COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
FDA Recall
Open, Classified
·Medtronic Inc.·Product code LWS·April 16, 2024
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
FDA Recall
Open, Classified
·Medtronic Inc.·Product code LWS·April 16, 2024
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
FDA Recall
Open, Classified
·Medtronic Inc.·Product code LWS·April 16, 2024