34 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-107-030D
FDA Recall
Completed
·Stryker Corporation·Product code HBE·July 24, 2024
Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-013-030DC
FDA Recall
Completed
·Stryker Corporation·Product code HBE·July 24, 2024
Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-107-530
FDA Recall
Completed
·Stryker Corporation·Product code HBE·July 24, 2024
Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-012-020D
FDA Recall
Completed
·Stryker Corporation·Product code HBE·July 24, 2024
Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-012-040D
FDA Recall
Completed
·Stryker Corporation·Product code HBE·July 24, 2024
Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-012-030D
FDA Recall
Completed
·Stryker Corporation·Product code HBE·July 24, 2024
Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-009-030
FDA Recall
Completed
·Stryker Corporation·Product code HBE·July 24, 2024
Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-009-040
FDA Recall
Completed
·Stryker Corporation·Product code HBE·July 24, 2024
Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-013-050DC
FDA Recall
Completed
·Stryker Corporation·Product code HBE·July 24, 2024
Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-013-040DC
FDA Recall
Completed
·Stryker Corporation·Product code HBE·July 24, 2024
Revolution CT
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·July 14, 2021
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
FDA Enforcement
Class II
·Completed·Fresenius Medical Care Holdings, Inc.·November 18, 2020
VariCam
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·January 16, 2019
VariCam
FDA Recall
Completed
·GE Healthcare, LLC·Product code KPS·October 30, 2017
Discover VH/Millennium VG Nuclear Medicine Imaging System
FDA Recall
Completed
·GE Healthcare, LLC·Product code KPS·October 30, 2017
Revolution CT
FDA Recall
Completed
·GE Healthcare, LLC·Product code JAK·March 19, 2021
Discover VH/Millennium VG Nuclear Medicine Imaging System
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·January 16, 2019
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781315
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021