323 results
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17ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II LVAS Implant Kit, OUS REF 102139 2. HeartMate II LVAS Implant Kit, US REF 1355 3. HeartMate II LVAS Implant Kit (with RSOC Controller), US REF 103695 4. HeartMate II LVAS Implant Kit (with RSOC Controller), OUS REF 103693 5. HeartMate II LVAS Implant Kit (with Sealed Graft), US REF 104911 6. HeartMate II LVAS Implant Kit (with Sealed Graft), OUS REF 104912 7. HeartMate II LVAS Implant Kit (Used for pump exchange, No Graft) REF 107801 8. HeartMate II LVAS Implant Kit, (EPC), CANADA REF 103695-CAN 9. HeartMate II LVAS Implant Kit (with Sealed Graft), JAPAN REF 104911JPN 10. HeartMate II LVAS Implant Kit (with Pocket System Controller and Sealed Grafts), for geographies outside of US & EU REF 106515OUS HeartMate II Left Ventricular Assist System: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system. One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries.
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·March 27, 2024
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Product Usage: Breast augmentation and Breast reconstruction
FDA Enforcement
Class I
·Ongoing·Allergan PLC·September 18, 2019
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
FDA Enforcement
Class I
·Ongoing·Draeger Medical, Inc.·March 1, 2023
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
FDA Enforcement
Class I
·Ongoing·Draeger Medical, Inc.·March 1, 2023
AirTouch N20 Nasal Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirFit F30 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirTouch F20 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirFit F30i Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
AirFit N10 Nasal Masks and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
FDA Enforcement
Class I
·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 28, 2018
AirFit N20 Nasal Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
HeartWare HVAD Implant Kit, REF 1104JP
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·August 18, 2021
HeartWare HVAD Implant Kit, REF MCS1705PU
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·August 18, 2021
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025
AirFit F20 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·June 3, 2020
Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·April 7, 2021
Inspire Model 3028, IV Implantable Pulse Generator
FDA Enforcement
Class I
·Ongoing·Inspire Medical Systems Inc.·July 3, 2024