815 results
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11ms
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Sources: EU EUDAMED, US FDA
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
FDA Enforcement
Class I
·Ongoing·Abbott·July 19, 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
Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·October 9, 2013
Impella LD intravascular micro axial blood pump, Product Number 005082
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·July 26, 2023
Impella 2.5 intravascular micro axial blood pump, Product Number 005042
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·July 26, 2023
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·July 26, 2023
Impella CP intravascular micro axial blood pump, Product Number 0048-0032
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·July 26, 2023
Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·July 26, 2023
Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·July 26, 2023
HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to the heart and is designed to assist or take over the pumping function of the patients left ventricle, the main pumping chamber of the heart.
FDA Enforcement
Class I
·Terminated·Thoratec Corporation·April 2, 2014
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required.
FDA Enforcement
Class I
·Terminated·Hospira Inc.·May 8, 2013
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required.
FDA Enforcement
Class I
·Terminated·Hospira Inc.·May 8, 2013
SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.
FDA Enforcement
Class I
·Terminated·ICU Medical, Inc.·April 24, 2019
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.
FDA Enforcement
Class I
·Terminated·ICU Medical, Inc.·April 24, 2019
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.
FDA Enforcement
Class I
·Terminated·ICU Medical, Inc.·April 24, 2019
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
FDA Enforcement
Class I
·Ongoing·Abbott Diabetes Care, Inc.·January 21, 2026
Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Custom procedural trays or kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
FDA Enforcement
Class I
·Terminated·Merit Medical Systems, Inc.·February 26, 2014
CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
FDA Enforcement
Class I
·Terminated·Cardiovascular Systems, Inc.·August 20, 2014
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
Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·December 30, 2015