5 results
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25ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.
FDA Enforcement
Class II
·Terminated·Schaerer Medical USA Inc·November 16, 2016
Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.
FDA Enforcement
Class II
·Terminated·Schaerer Medical USA Inc·November 16, 2016
uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
FDA Enforcement
Class II
·Terminated·Ulrich Medical USA Inc·May 3, 2017
ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
FDA Enforcement
Class II
·Terminated·ulrich medical USA Inc·April 17, 2019
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
FDA Enforcement
Class II
·Terminated·ulrich medical USA Inc·March 4, 2020