BEUDAMED
    73 results · 24ms · Sources: EU EUDAMED, US FDA

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    Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/A

    FDA Recall
    Open, Classified ·TruAbutment Inc.·Product code NDP·December 27, 2023

    Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S

    FDA Recall
    Open, Classified ·EMPATICA SRL Via Enrico Stendhal·Product code POS·July 13, 2023

    Flow-i C40 Anesthesia System, model 6677400

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code BSZ·December 11, 2023

    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 Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code BSZ·May 1, 2024

    9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code BSZ·September 17, 2020

    PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.

    FDA Recall
    Open, Classified ·Envisiontec US Llc·Product code EBZ·January 20, 2022

    GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code BSZ·May 27, 2022

    Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BSZ·July 12, 2024

    Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BSZ·July 12, 2024

    Atlan A350XL. Model Number: 8621600. anesthesia workstation

    FDA Recall
    Open, Classified ·Draeger, Inc.·Product code BSZ·May 7, 2026

    GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025

    GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025

    Flow-e Anesthesia System, model 6887900

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code BSZ·December 11, 2023

    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger Medical, Inc.·Product code BSZ·October 15, 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 Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code BSZ·January 15, 2025

    Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.

    FDA Recall
    Open, Classified ·Mindray DS USA, Inc. dba Mindray North America·Product code BSZ·October 20, 2025

    Flow Sensor Service Part, Catalog 2087640-001-S

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code BSZ·September 17, 2020

    Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BSZ·July 12, 2024

    Flow-c Anesthesia System, model 6887700

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code BSZ·December 11, 2023

    Getinge Flow-e Anesthesia System, Part No. 6887900

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code BSZ·December 22, 2022