8 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S
FDA Enforcement
Class II
·Terminated·NewDeal SA·July 25, 2018
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·August 25, 2021
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
FDA Enforcement
Class II
·Completed·Basic Reset Inc.·November 20, 2019
TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S
FDA Enforcement
Class II
·Terminated·NewDeal SA·July 25, 2018
Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. Product Usage: Total or partial replacement of the Gleno-humeral articulation.
FDA Enforcement
Class II
·Terminated·Tornier, Inc·December 14, 2016
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
FDA Enforcement
Class II
·Ongoing·FX SHOULDER·February 7, 2024
Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
FDA Enforcement
Class II
·Terminated·Fx Solutions·July 25, 2018
Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
FDA Enforcement
Class II
·Terminated·Fx Solutions·July 25, 2018