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Sources: EU EUDAMED, US FDA
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Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization.
FDA Enforcement
Class II
·Terminated·Getinge USA Inc·August 28, 2013
Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128
FDA Enforcement
Class II
·Terminated·Getinge USA Inc·August 1, 2012
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F0
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·November 20, 2024
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
FDA Enforcement
Class I
·Ongoing·Getinge Usa Sales Inc·February 19, 2025
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item Number: 720001B0
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·November 20, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F2
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·November 20, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001B0
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·November 20, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·November 20, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001B2
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·November 20, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001F0
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·November 20, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·November 20, 2024
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·July 17, 2024
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·July 17, 2024
Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.
FDA Enforcement
Class I
·Ongoing·Getinge Usa Sales Inc·June 12, 2024
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·July 17, 2024
Flow-i C30 Anesthesia System, model 6677300
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·February 14, 2024
Flow-i C20 Anesthesia System, model 6677200
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·February 14, 2024
Flow-e Anesthesia System, model 6887900
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·February 14, 2024
Flow-i C40 Anesthesia System, model 6677400
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·February 14, 2024
Flow-c Anesthesia System, model 6887700
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·February 14, 2024