74 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which is placed, during arthroplasty, in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes to meet various anatomical variations and is supplied sterile. Component: N/A
FDA Recall
Open, Classified
·Osteotec Limited·Product code KYJ·June 18, 2025
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
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
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000
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 650c A1, Model/REF Number 1012-9655-200
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025