335 results
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14ms
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Sources: EU EUDAMED, US FDA
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 Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·December 20, 2023
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
FDA Enforcement
Class I
·Ongoing·Maquet Medical Systems USA·December 13, 2023
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·August 20, 2025
Drager SafeStar 55, Catalog No. MP01790
FDA Enforcement
Class I
·Ongoing·Draeger Medical, Inc.·June 22, 2022
iQ 2 Nasal Vented Mask
FDA Enforcement
Class I
·Ongoing·SleepNet Corporation·April 10, 2024
Phantom 2 Nasal Vented Mask
FDA Enforcement
Class I
·Ongoing·SleepNet Corporation·April 10, 2024
Mojo Full Face with Headgear, All Sizes
FDA Enforcement
Class I
·Ongoing·SleepNet Corporation·April 10, 2024
Mojo 2 Full Face Vented Mask, All Sizes
FDA Enforcement
Class I
·Ongoing·SleepNet Corporation·April 10, 2024
Mojo 2 Full Face Non Vented Mask, All Sizes
FDA Enforcement
Class I
·Ongoing·SleepNet Corporation·April 10, 2024
Mojo 2 Full Face AAV Non Vented Mask, All Sizes
FDA Enforcement
Class I
·Ongoing·SleepNet Corporation·April 10, 2024
Mojo Non Vented Full Face Mask with Headgear, All Sizes
FDA Enforcement
Class I
·Ongoing·SleepNet Corporation·April 10, 2024
COVID-19 Self-Test Kit *** INNOVA *** 3T
FDA Enforcement
Class I
·Ongoing·INNOVA MEDICAL GROUP, INC.·June 16, 2021
COVID-19 Self-Test Kit *** INNOVA *** 7T
FDA Enforcement
Class I
·Ongoing·INNOVA MEDICAL GROUP, INC.·June 16, 2021
Cub 2 Enclosed Bed Canopy System
FDA Enforcement
Class I
·Ongoing·Sensory Medical Inc·April 20, 2022
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·May 28, 2025
Servo-n Ventilator System. Model Number: 6694800.
FDA Enforcement
Class I
·Ongoing·Maquet Critical Care AB·July 9, 2025
Servo-u Ventilator System. Model Number: 6688600.
FDA Enforcement
Class I
·Ongoing·Maquet Critical Care AB·July 9, 2025
Servo-u MR Ventilator System. Model Number: 6888800.
FDA Enforcement
Class I
·Ongoing·Maquet Critical Care AB·July 9, 2025
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·June 11, 2025