17 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
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 Recall
Open, Classified
·WANDERCRAFT SAS·Product code PHL·April 3, 2025
CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprofessionalsasdiagnosticsupportforpediatricandadultpatients.
FDA Recall
Open, Classified
·Trophy SAS Trophy Sas Trophy; Croissy Beaubourg·Product code OAS·July 21, 2021
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code LLZ·September 5, 2025
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code OWB·March 18, 2024
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
FDA Recall
Open, Classified
·GE Medical Systems SCS·Product code LLZ·May 8, 2026
GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code OWB·March 18, 2024
GE Healthcare Innova IGS 5, computed tomography x-ray system
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code OWB·March 18, 2024
GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code OWB·March 18, 2024
GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code OWB·March 18, 2024
GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code OWB·March 18, 2024
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code OWB·March 18, 2024
Senographe Pristina
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code MUE·December 26, 2023
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 EleganceAnterior 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 Eleganceplates, 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 EleganceAnterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.
FDA Recall
Open, Classified
·Clariance-SAS 18 Rue Robespierre Beaurains France·Product code KWQ·February 20, 2026
I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
FDA Recall
Open, Classified
·In2Bones, SAS 28 Chemin du petit Bois Ecully France·Product code HWC·January 26, 2024
I.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
FDA Recall
Open, Classified
·In2Bones, SAS 28 Chemin du petit Bois Ecully France·Product code HWC·January 26, 2024
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
FDA Recall
Open, Classified
·MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France·Product code HAW·September 22, 2021
HIGH V+ Spinal Cement System REF T040321K
FDA Recall
Open, Classified
·TEKNIMED SAS Zone Industrielle Montredone 11 Rue D Apollo L'Union France·Product code NDN·December 15, 2022