46 results
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25ms
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Sources: EU EUDAMED, US FDA
GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Innova IGS 5, computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems, SCS·July 18, 2018
Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems, SCS·July 18, 2018
Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems, SCS·July 18, 2018
Senographe Pristina
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·February 14, 2024
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·October 15, 2025
Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The Elegance¿Anterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance¿ Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance¿plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance¿ Anterior Cervical plate. Detailed information concerning the surgical technique of the Elegance¿Anterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.
FDA Enforcement
Class II
·Ongoing·Clariance-SAS·April 22, 2026
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
FDA Enforcement
Class II
·Ongoing·WANDERCRAFT SAS·May 14, 2025
CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
FDA Enforcement
Class II
·Terminated·Trophy Sas·May 8, 2013
CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
FDA Enforcement
Class II
·Terminated·Trophy Sas·May 8, 2013
DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
FDA Enforcement
Class II
·Terminated·In2Bones, SAS·April 1, 2015
NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius
FDA Enforcement
Class II
·Terminated·In2Bones, SAS·January 18, 2017
NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius
FDA Enforcement
Class II
·Terminated·In2Bones, SAS·January 18, 2017
SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius
FDA Enforcement
Class II
·Terminated·In2Bones, SAS·January 18, 2017