12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Completed
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CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
FDA Recall
Completed
·Caire, Inc.·Product code CAW·October 4, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
FDA Recall
Completed
·Caire, Inc.·Product code CAW·October 4, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
FDA Recall
Completed
·Caire, Inc.·Product code CAW·October 4, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
FDA Recall
Completed
·Caire, Inc.·Product code CAW·October 4, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
FDA Enforcement
Class II
·Completed·Caire, Inc.·November 27, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
FDA Enforcement
Class II
·Completed·Caire, Inc.·November 27, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
FDA Enforcement
Class II
·Completed·Caire, Inc.·November 27, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
FDA Enforcement
Class II
·Completed·Caire, Inc.·November 27, 2024
Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.
FDA Recall
Completed
·IMPERATIVE CARE INC·Product code NRY·August 13, 2021
Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.
FDA Enforcement
Class I
·Completed·IMPERATIVE CARE INC·October 6, 2021
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
FDA Recall
Completed
·Abbott Diabetes Care, Inc.·Product code QLG·February 9, 2023
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
FDA Enforcement
Class II
·Completed·Abbott Diabetes Care, Inc.·January 24, 2024