5 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·March 1, 2017
TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·November 5, 2014
MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
FDA Enforcement
Class II
·Terminated·Stryker Craniomaxillofacial Division·February 18, 2015
Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).
FDA Enforcement
Class II
·Terminated·TITAN SPINE, LLC·April 1, 2015
P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only
FDA Enforcement
Class II
·Terminated·Paragon 28, Inc.·December 18, 2019