9 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter and the cage and then rotate for desired placement. The three components of the TL Steerable Inserter System include: 1. TL Steerable Inserter 2. TL Steerable Inserter Inner Shaft 3. TL Steerable Inserter Driver
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·October 31, 2018
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
FDA Enforcement
Class II
·Ongoing·Btt Health Gmbh·September 25, 2024
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.
FDA Enforcement
Class II
·Completed·CTL Medical Corporation·July 15, 2020
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.
FDA Enforcement
Class II
·Completed·CTL Medical Corporation·July 15, 2020
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.
FDA Enforcement
Class II
·Completed·CTL Medical Corporation·July 15, 2020
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.
FDA Enforcement
Class II
·Completed·CTL Medical Corporation·July 15, 2020
Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar.
FDA Enforcement
Class II
·Terminated·BTE Technologies, Inc.·July 15, 2015
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
FDA Enforcement
Class II
·Terminated·CTL Medical Corporation·March 27, 2019
CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
FDA Enforcement
Class II
·Terminated·CTL Medical Corporation·March 27, 2019