196 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Widefield OCT software feature for the Spectralis HRA+OCT and variants
FDA Recall
Terminated
·Heidelberg Engineering·Product code OBO·December 8, 2017
Widefield OCT software feature for the Spectralis HRA+OCT and variants
FDA Enforcement
Class II
·Terminated·Heidelberg Engineering·May 2, 2018
The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid. The PLEX Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.
FDA Recall
Terminated
·Carl Zeiss Meditec, Inc.·Product code OBO·October 16, 2018
The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid. The PLEX Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·January 8, 2020
Cirrus HD-OCT Model 400 instruments; new and refurbished, with or upgraded to, version 4.6 or 5.1.0 software. The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device.
FDA Recall
Terminated
·Carl Zeiss Meditec Inc·Product code OBO·March 10, 2011
Cirrus HD-OCT Model 4000 instruments, new and refurbished, distributed with, or upgraded to, version v 1.0 - 4.5, 5.0.0 or 5.1.0 The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device.
FDA Recall
Terminated
·Carl Zeiss Meditec Inc·Product code OBO·March 10, 2011
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
FDA Recall
Terminated
·Zimmer Spine, Inc.·Product code KWP·February 3, 2016
Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument) or 2660022119710 (refurbished instrument), and Stratus 6.0.0 Software Kit, product number 2660021133164. The Stratus OCT is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer, macula, and optic disk. The Stratus OCT with Retinal Nerve Fiber Layer and Macula Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including, but not limited to, macular edema, central serous retinopathy, and glaucoma.
FDA Recall
Terminated
·Carl Zeiss Meditec Inc·Product code HLI·July 31, 2009
ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·June 12, 2013
Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only
FDA Recall
Terminated
·Zimmer Biomet Spine, Inc·Product code MAX·March 16, 2017
Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only
FDA Enforcement
Class II
·Terminated·Zimmer Biomet Spine, Inc·April 5, 2017
RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
FDA Recall
Terminated
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWP·March 18, 2016
Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·July 20, 2016
RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
FDA Enforcement
Class II
·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·April 20, 2016
Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
FDA Recall
Terminated
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWP·April 22, 2016
Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
FDA Enforcement
Class II
·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·June 1, 2016
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·June 12, 2013
Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·July 20, 2016
Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results.
FDA Enforcement
Class II
·Terminated·Richard-Allan Scientific Company·May 27, 2015
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
FDA Recall
Terminated
·ulrich medical USA Inc·Product code KWP·December 31, 2019