14 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387307, .035/150cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387312, .035/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG087312, .035/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387320, .038/180cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387324, .038/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387311, .035/180cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387309, .035/300cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387308, .035/180cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387319, .038/150cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387310, .035/150cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 22G X 1.5 inch Product Number: 5551822215
FDA Recall
Terminated
·Kendall Healthcare Products Co·Product code FMI·October 8, 2004
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016