5 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·January 24, 2024
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
FDA Enforcement
Class II
·Ongoing·SIN SISTEMA DE IMPLANTE NACIONAL S.A·January 22, 2025
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
FDA Enforcement
Class II
·Ongoing·Oculus Technologies of Mexico, S.A. de C.V.·June 10, 2026
abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Large REF BC21273 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Medium REF BC21089
FDA Enforcement
Class III
·Ongoing·S & MOHR AMERICA, S.A. DE C.V.·March 1, 2023
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·September 4, 2024